News

PROTECT-AF trial of Watchman LAAC (Boston Scientific) successful for Stroke Prevention

Four-year follow-up data from the PROTECT AF clinical trial demonstrated the Watchman Left Atrial Appendage (LAA) Closure device, from Boston Scientific, was statistically superior to warfarin for preventing cardiovascular death, all-cause Stroke and systemic embolization. The data demonstrated significant reductions in both cardiovascular and all death compared to warfarin.

The observed primary efficacy event rate was 2.3 percent and 3.8 ...

Trial shows Vascazen (Pivotal Therapeutics) effective in altering cholesterol levels in patients with CV Risk

A trial has demonstrated that Vascazen (omega-3 oil), from Pivotal Therapeutics, is highly effective in correcting an omega-3 deficiency. The company suggests this could have benefits for people at risk of developing CardioVascular Disease. In eight weeks of treatment a statistically significant (p<0.0001) increase of 121% in the Omega-Score and 112% (p<0.0001) in Omega-Index (the blood levels of EPA, DHA ...

Four year follow up on EVEREST II study of Mitra Clip (Abbott)

Four-year follow-up of the Endovascular Valve Edge-to-Edge Repair Study II (EVEREST II) show no differences in the primary end point between the Mitra Clip (Abbott) procedure and surgery and significantly more follow-up surgeries for residual mitral regurgitation (MR) in the clip group.At four years, surgery for mitral-valve dysfunction was needed for one out of every four patients treated with the ...

FDA approves Liptruzet (Merck Inc) for Dyslipidaemia

The FDA has approved Liptruzet (ezetimibe and atorvastatin) tablets, from Merck Inc, for the treatment of Dyslipidaemia. It is indicated for elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. Approval is based on results including a multicenter, clinical study in which 628 patients with hyperlipidemia ...

Phase III trial shows benefits of Resolute ZES (Medtronic) in CAD patients with Diabetes

New data shows that treatment with the Resolute (zotarolimus-eluting stent), from Medtronic, led to positive outcomes for CAD patients with Diabetes who were not taking insulin and for CAD patients without Diabetes. It presents the results of two analyses from the Phase III RESOLUTE program, which enrolled a total of 5,130 patients. This set a 12-month target vessel failure (TVF) ...

REMEDEE study of COMBO Dual Therapy Stent (Orbus Neich) meets primary endpoint

Data from the REMEDEE study of the COMBO Dual Therapy Stent, from Orbus Neich, demonstrated that the stent met the study's primary endpoint in CAD patients and was found to be effective in controlling neointimal proliferation. Specifically, the COMBO Stent was shown to be non-inferior to a drug eluting stent (DES) with respect to angiographic in-stent late lumen loss at ...

IQWiG report on Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation

The Institute for Quality and Efficiency in Healthcare (IQWiG)in Germany said that Eliquis (apixaban) from BMS and partner Pfizer Inc.has "significant" additional benefit to prevent Stroke and Systemic Embolism in adults with non-valvular atrial fibrillation (AF) with one or more risk factors -- an indication approved by the European Commission in November.

IQWiG said Eliquis provides "significant" additional ...

CHMP recommends Xarelto (Bayer) for prevention of atherosclerotic events after ACS

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice-daily in combination with standard antiplatelet therapy for the prevention of atherothrombotic events (myocardial infarction, cardiovascular death or stroke) after an Acute Coronary Syndrome (ACS) in adult patients with elevated cardiac biomarkers. Elevated cardiac biomarkers confirm the ...

FDA approves AdreView (GE HealthCare) for gamma scintigraphic assessment of Heart Failure

The FDA has on 22 March 2013, approved an extension to the indication of AdreView (Iobenguane I 123 Injection) from GE HealthCare for the scintigraphic assessment of Myocardial Sympathetic Innervation (cardiac nerve activity) to assist in the evaluation of patients with New York Heart Association (NYHA) Class II or Class III Heart Failure and Left Ventricular Ejection Fraction (LVEF) ...

CHMP restricts use of Pletal(Otsuka)and Ekistol(Lacer) to treat Intermittant Claudication

The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has recommended that the use of cilostazol-containing medicines in the treatment of Intermittent Claudication – a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk – should be restricted with a range of new measures aimed at targeting a ...

FDA Advisory Committee recommends MitraClip (Abbott Vascular)to treat Mitral Regurgitation

The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has on 20 March 2013, voted by majority (Yes: 5, No: 3) that the benefits of treatment with the MitraClip device from Abbott Vascular, outweigh its risks in patients with significant symptomatic mitral regurgitation (MR) who have been determined by a cardiac surgeon to be too high ...

CHMP rejects Defitelio (Gentium/SOBI)for Hepatic Veno- Occlusive disease

On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Defitelio (defibrotide) from Gentium/Swedish Orphan Biovitrium)intended for the treatment and prevention of Hepatic Veno-Occlusive disease in blood stem cell transplantation therapy. The drug was withdrawn from the FDA in August 2011.

Orbit Artherectomy System (Cardiovascular Systems) filed at FDA to treat Calcified Arteries

Cardiovascular Systems (CSI) has announced it has submitted its Premarket Approval (PMA) application to the FDA for its Orbital Atherectomy System, used to treat calcified coronary arteries.

The completed PMA application marks another major coronary milestone for CSI, following the release of ORBIT II pivotal trial results at the recent 2013 American College of Cardiology (ACC) conference. CSI's technology ...

Inspra(Pfizer) success in REMINDER trial for acute STEMI patients

Pfizer Inc. announced results from the REMINDER trial of Inspra (eplerenone) showing statistically significant risk reductions in the primary composite efficacy endpoint. The composite endpoint was defined as the time to first event of cardiovascular (CV) mortality, re-hospitalization or extended initial hospital stay due to diagnosis of Heart Failure (HF), sustained ventricular tachycardia or fibrillation, ejection fraction (EF) 40% ...

EU approves Carotid Embolic Protection Stent (InspireMD) for Stroke prevention

InspireMD's Carotid Embolic Protection Stent has received CE mark approval in the EU. It is based on MicroNet mesh technology, designed to provide procedural and post-procedural distal embolic protection in carotid artery stenting procedures to reduce the risk of Stroke. The MicroNet is designed to hold plaque and thrombus in place against the wall of the blocked artery, preventing debris ...

STREAM Trial shows that Metalyse/TNKase (Boehringer) offers some benefits in STEMI patients

Results from the STREAM trial of 1,915 patients with ST-elevation myocardial infarction (STEMI), given Metalyse/TNKase (tenecteplase), from Boehringer, indicates that the drug offers some benefits compared to alternative PCI treatment. Patients were seen in community hospitals or by emergency medical personnel where angioplasty was not possible. Before transfer, subjects were randomized to either percutaneous coronary intervention immediately after arrival or ...

Study shows Metalyse/TNKase (Boehringer) benefits patients with Pulmonary Embolism

A new study shows that in patients with Acute Pulmonary Embolism, Metalyse/TNKase (tenecteplase), from Boehringer, prevents death or circulatory collapse and is particularly effective for patients aged below 75 years. The prospective, randomized, double blind PEITHO study enrolled 1,006 patients with confirmed APE. Patients were assigned heparin plus tenecteplase or heparin plus placebo. The primary endpoint was death from any ...

CHAMPION PHOENIX Phase III trial of cangrelor (Medicines Company) success in PCI

The Medicines Company has reported results of CHAMPION PHOENIX, a 11,145 patient Phase III randomized, double-blind clinical trial comparing the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing Percutaneous Coronary Intervention (PCI).

Patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ...

Positive results in three-year trial of Absorb Vascular Scaffold (Abbott)

Three-year results from 101 patients treated with the Absorb Vascular Scaffold (bioresorbable everolimus eluting stent system), from Abbott, in the second stage of the ABSORB trial show that improvements are seen in blood vessel movement and area inside the vessel where the scaffold was placed. Results showed the rate of major adverse cardiovascular events (MACE) in 101 patients was 10 ...

Ranexa(Gilead Sciences) success in Phase IV TERISA trial to treat Chronic Stable Angina in diabetic patients.

Gilead Sciences, has announced data from the Phase IV TERISA (Type 2 Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) study, which demonstrated that the addition of Ranexa (ranolazine) to background antianginal therapy in chronic angina patients with Type 2 Diabetes significantly reduced the frequency of weekly angina episodes compared to placebo and background antianginal therapy. Results ...

Xarelto(Bayer/Janssen) initiates trial for non valvular Atrial Fibrillation

Bayer HealthCare announced the initiation of the PIONEER AF-PCI study, a Phase IIIb clinical study of its oral anticoagulant Xarelto (rivaroxaban) to investigate how best to treat patients with non-valvular Atrial Fibrillation who undergo Percutaneous Coronary Intervention with stent placement.

The PIONEER AF-PCI study will enroll approximately 2,100 patients worldwide. The trial will assess the safety of two ...

Promus Element stent (Boston Scientific) continues to outperform the Xience V stent at 3 years

At three years, the Promus Element everolimus eluting stent, from Boston Scientific, continued to demonstrate advantages for CAD patients over the Xience V Stent. The trial reported a three-year target lesion revascularization (TLR) rate of 3.5 percent for the Promus Element Stent, the lowest TLR rate in any pivotal FDA approval trial, compared to 4.9 percent for the Xience V ...

Trial of Stentys self-apposing stent (Stentys) demonstrates low mortality rates in CAD patients

One-year results of the APPOSITION III clinical trial in 1000 CAD patients post treatment of a severe heart attack show that the Stentys Self-Apposing Stent, from Stentys, demonstrates low mortality rates in patients. The APPOSITION III trial is a prospective single-arm multi-center study designed to assess the long term performance of Stentys Self-Apposing Stents in routine clinical practice in Europe ...

PREVAIL trial of Watchman LAAC (Boston Scientific) shows some benefits for AF patients

New results on the PREVAIL trial, which randomized 407 patients with nonvalvular Atrial Fibrillation to either LAA closure with the Watchman device, from Boston Scientific or warfarin, indicates the study has met 2 of its 3 primary end points. Data shows that the device was implanted more successfully in the trial (95.1%) than in 2 prior Watchman studies: PROTECT AF ...

MitraClip System (Abbott Vascular) success in EVEREST II trial for reatment of Mitral Regurgitation

Abbott announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the company's first-in-class catheter-based MitraClip System for the treatment of Mitral Regurgitation (MR). Findings were presented at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco

Results showed: A 30-day mortality rate significantly lower than ...

Xarelto enters Phase III trial for Heart Failure and CAD

Bayer HealthCare and Janssen Research & Development, LLC announced the initiation of COMMANDER-HF, a pivotal Phase III clinical trial that will evaluate Xarelto (rivaroxaban) 2.5 mg twice daily in patients with Chronic Heart Failure (HF) and significant coronary artery disease (CAD). Rivaroxaban is the first novel oral anticoagulant to be evaluated in this patient group who remain at high-risk for ...

Study reveals mechanism providing benefit of omega-3 fatty acids on Cardiovascular health

A new study has uncovered a mechanism by which omega-3 fatty acids can benefit Cardiovascular health. Prof. Heinemann (Jena University), Prof. Dr. Michael Bauer (Jena University Hospital) and Prof. Dr. Toshinori Hoshi (University of Pennsylvania) have shown that the 'SLO1' potassium channel is an important component in the effectiveness of omega-3 fatty acids. These ionic channels act like very specific ...

FDA rejects again Xarelto ( Janssen/Bayer) for treatment of Acute Coronary Syndrome

The FDA has rejected for the second time, the supplemental new drug application for Xarelto (rivaroxaban) from Janssen Pharma/Bayer as a therapy to reduce the risk of cardiovascular events in patients with Acute Coronary Syndrome (ACS). The drug was rejected last June after the Cardiovascular and Renal Drugs Advisory Committee a month earlier voted 6-4, with one abstention, against approval ...

EU approves Promus Premier Stent (Boston Scientific) for treating CAD

Boston Scientific has received CE Mark approval for the Promus Premier everolimus-eluting platinum chromium Coronary Stent System, the company's next-generation polymer drug-eluting stent (DES) technology for treating Coronary Artery Disease, and is starting its European market launch. The Promus Premier features a customized Platinum Chromium (PtCr) stent architecture, the everolimus drug coating and fluorinated co-polymer, and an enhanced stent delivery ...

Two trials demonstrate benefits of Pradaxa/Rendix (Boehringer) for patients with VTE

New findings from two double-blind, randomized trials, RE-MEDYSM and RE-SONATE, show that Pradaxa/Rendix (dabigatran etexilate), from Boehringer, reduces the risk of recurrent Venous ThromboEmbolism (VTE). RE-MEDY demonstrated that treatment with dabigatran 150 mg twice daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, including VTE-related death. RE-SONATE demonstrated dabigatran was superior to placebo for the prevention of first recurrent ...

Gentium unlikely to get CHMP recommendation for defibrotide use in Hepatic Veno-Occlusive disease

Gentium S.p.A. had presented an oral explanation at the EMA Committee for Medicinal Products for Human Use ("CHMP") as part of its Marketing Authorization Application for Defibrotide to treat and prevent Hepatic Veno-Occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. Following the oral explanation,based on preliminary feedback from the CHMP,the Company expects an opinion recommending ...

St.Jude Medical initiates trial of EnligHTN system for CV Risk reduction

St. Jude Medical, Inc. has announced plans for a new landmark study that will evaluate whether renal denervation and medication can provide health benefits to patients beyond lowering high blood pressure. The EnligHTNment trial is the first large-scale study that will examine the long-term effects of the EnligHtN System of renal denervation in patients who have uncontrolled hypertension to see ...

FDA approves Aorfix (Lombard Medical) for treatment of Abdominal Aortic Aneurysms

Lombard Medical Technologies PLC, the specialist medical technology company focused on innovative vascular products, announced on 15 February 2013 that Aorfix has been approved for commercial sale in the U.S. by the FDA.

Aorfix is a flexible stent graft for the endovascular repair of Abdominal Aortic Aneurysms ("AAAs"). Data from the U.S. PYTHAGORAS trial of Aorfix, has demonstrated that ...

EU approves Ilesto 7 (Biotronik) for patients with Heart Failure

The Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series, from Biotronik, has received CE approval in the EU for patients with Heart Failure who require resynchronisation therapy. The Ilesto 7 series includes one of the world’s smallest ICDs and features ProMRI technology, which enables access to potentially life-saving MR scans. The Ilesto offers patients and physicians the greatest longevity ...

Treprostinil diolamine extended release tablets (United Therapeutics) re-filed at FDA for treatment of PAH

United Therapeutics Corporation has announced that the FDA has acknowledged the re-submission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of Pulmonary Arterial Hypertension. The FDA classified the re-submission as a complete, class 1 response to the FDA Complete Response Letter and set a user fee goal date of March 31, ...

Bayer files riociguat for CTEPH and Pulmonary Arterial Hypertension at FDA and EU

Bayer HealthCare has submitted the oral investigational drug riociguat to treat patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH) for regulatory approval in the United States and in the European Union. Riociguat was discovered by Bayer and represents the first member of a novel class of compounds, the stimulators of soluble guanylate cyclase. Riociguat ...

Success for Solitaire FR (Covidien) in STAR revasculization study

Covidien reports results from the two year Solitaire FR Thrombectomy for Acute Revasculization study(STAR study). The prospective, multi-center, single arm clinical study started with an enrollment of 202 patients at 14 centers across Europe, Australia and Canada in May 2010. In the study, patients diagnosed with Acute Ischaemic Stroke (AIS) (as confirmed by radiographic assessment) were treated with the ...

FDA approves Kynamro (Genzyme/Sanofi) to treat Homozygous Familial Hypercholesterolemia

The FDA 0n 29 January 2013 approved Kynamro (mipomersen sodium) injection, from Genzyme/Sanofi, as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called Homozygous Familial Hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).

HoFH, an ...

Novartis withdraws application at EMA for Ruvise treatment for PAH

The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Ruvise (imatinib mesilate), 100- and 400-mg film-coated tablets. It was intended to be used for adults as add-on therapy for the treatment of Pulmonary Arterial Hypertension.

The company stated that it is ...

NICE recommends Eliquis (Pfizer/BMS) for Stroke Prevention

NICE (The National Institute of Health and Clinical Excellence) has recommended the oral anticoagulant Eliquis (apixaban) from BMS and Pfizer, as an option for Prevention of Sroke and Systemic Embolism in people with non-valvular Atrial Fibrillation with one or more risk factors.

The NICE appraisal committee considered that Eliquis was cost effective and more clinically effective for reducing stroke and ...

CE Mark granted to st Jude Medical for Amplatzer LAA Occluder

European CE Mark approval is granted to St. Jude Medical for its Amplatzer Amulet Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). According to research, AF leads to an increased risk for stroke. Sealing off the LAA helps prevent the risk of blood clot ...

Cinryze(ViroPharma) success in paediatric Hereditary Angio-Oedema

New data demonstrates that use of Cinryze (C1 esterase inhibitor [human]), from Viro Pharma, in pediatric patients provided relief from symptoms of Hereditary Angio-Oedema (HAO) attacks and reduced the rate of attacks. In the study, children had a nearly twofold reduction in number of HAE attacks while receiving Cinryze for prophylaxis compared with the time period during which they received ...

Merck Inc,. withdraws Tredaptive treatment for Dyslipidaemia

Merck Inc.,announced that it is taking steps to suspend the availability of Tredaptive (extended-release niacin/laropiprant) tablets worldwide. Tredaptive is not approved for use in the United States.

Merck is taking these steps based on the current understanding of the preliminary data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, ...

Cangrelor(The Medicines Company) success in Phase III trial for PCI

The Medicines Company has announced results for its pivotal Phase III clinical trial of cangrelor, which is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing percutaneous coronary intervention (PCI). Following the recommendation of the trial's Data Safety Monitoring Board (DSMB) in July 2012 to continue the protocol ...

Study finds CholestOff (Nature Made) reduces Cholesterol levels in patients with CV risk

A new study suggests CholestOff, a sterol/stanol ester-based softgel capsule, from Nature Made, offers benefits for decreasing LDL cholesterol in individuals with high Cholesterol levels. The randomized, placebo-controlled, crossover trial lasted 17 weeks during which all subjects followed a heart healthy diet (National Cholesterol Education Program TLC Diet). One group received a sterol/stanol softgel for 6 weeks while the other ...

FDA approves Xience Xpedition everolimus eluting cardiac stent (Abbott Vascular)

Abbott Vascular has announced that the Xience Xpedition Everolimus Eluting Coronary Stent System has received FDA approval and is launching immediately in the United States , providing physicians with a next-generation technology with the largest size matrix in the U.S. market.

Xience Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies. ...

FDA approves Eliquis (BMS/Pfizer) to reduce the risk of Stroke and Systemic Embolism

The FDA on 28 December 2012 approved the anti-clotting drug Eliquis (apixaban) from BMS/Pfizer, an oral tablet used to reduce the risk of Stroke and dangerous blood clots (Systemic Embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by ...

FDA approves Juxtapid (Aegerion Pharma) for patients with Homozygous Familial Hypercholesterolemia

The FDA has approved Juxtapid (lomitapide), from Aegerion Pharma, as an adjunct to diet and other lipid-lowering treatments to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density-lipoprotein cholesterol (non-HDL) in patients with Homozygous Familial Hypercholesterolemia (HoFH). The FDA based its approval on a pivotal Phase III study, which evaluated the safety and effectiveness of ...

Tredaptive (Merck Inc) fails in HPS2-THRIVE trial

The HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive(extended-release niacin/laropiprant) did not meet its primary endpoint. Merck Inc., and the investigators are informing regulatory agencies of these results. The company is also preparing communications to health care providers in countries where the medicine is currently available, and will continue to ...

Migalastat (Amicus/GSK) disappoints in Phase III trial for Fabry Disease

Amicus Therapeutics and GSK announced the 6-month primary treatment period results from the first Phase III global registration study (Study 011) of investigational oral migalastat HCl monotherapy in males and females with Fabry Disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay.

GL-3 clearance from the kidney interstitial capillaries is used as a ...

Further positive results for Symplicity (Medtronic) Renal Dernervation System

Medtronic, Inc. has announced one-year results from Symplicity HTN-2, the first randomized clinical trial investigating renal denervation for Resistant Hypertension, that were published online before print in Circulation, the Journal of the American Heart Association.

These data showed patients who initially received treatment with the Symplicity renal denervation system (n=47) sustained a significant drop in blood pressure (-28/-10 ...

CHMP rejects Kynamro (Sanofi) for treatment of Homozygous Familial Hypercholesterolemia

Genzyme, a Sanofi company and Isis Pharmaceuticals Inc. have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for Kynamro (mipomersen) for the treatment of patients with Homozygous Familial Hypercholesterolaemia (HoFH). Genzyme plans to request a re-examination of the CHMP Opinion....

The Medicines Company and BMS collaborate in marketing Recothrom for Haemostasis.

The Medicines Company and Bristol-Myers Squibb Company announced that the companies have signed a global license and two year collaboration for Recothrom, a recombinant thrombin approved by the FDA for use as a topical hemostat to control non-arterial bleeding during surgical procedures.Recothrom was approved by the FDA in January 2008 and is marketed in Canada by Bayer HealthCare....

Positive data from Phase III study of Eliquis (BMS/Pfizer) for VTE prevention

Results of the Phase III AMPLIFY-EXT trial evaluating Eliquis (apixaban), from BMS/Pfizer, vs placebo for preventing VTE, shows it demonstrated superiority in reducing recurrent VTE and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the Eliquis groups. Eliquis also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and ...

FDA approves Evarrest (Ethicon Biosurgery) for problematic bleeding during Surgery

The FDA has approved Evarrest fibrin sealant patch, from Ethicon Biosurgery, a product that rapidly aids in stopping problematic bleeding during Surgery. Evarrest consists of a coating of biologics and a flexible patch that work together to encourage the hemostasis process. Clinical studies demonstrate that Evarrest is 98% effective in stopping bleeding and maintaining hemostasis compared to the current standard ...

New analysis explains competing findings in studies of omega-3 fatty acids and impact on CV Risk

A new analysis has sorted through many of the competing findings from studies of omega-3 fatty acids, and helps to explain why so many of the studies seem to arrive at differing conclusions.

The study, by scientists in the Linus Pauling Institute at Oregon State University and published in the Journal of Lipid Research, concludes that both fish consumption and ...

Actelion submits Opsumit to EMA for treatment of PAH

Actelion has announced that the submission of the Marketing Authorisation Application for macitentan (Opsumit) for the treatment of patients with Pulmonary Arterial Hypertension to the EMA has been accepted. The FDA had already received the registration dossier on October 22nd 2012.

Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome ...

Phase III trial succes for perindopril/amlodipine combination (Xoma) for Hypertension

Xoma Corporation has announced the 837-patient Phase III PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) has demonstrated the fixed-dose combination (FDC) of perindopril arginine combined with amlodipine besylate is statistically significantly superior to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. This FDC, containing a patent-protected proprietary form ...

Positive results from two Phase III trials of Varisolve (BTG) as Varicose Vein treatment

Data from VANISH-1 and VANISH-2, the two US pivotal Phase III trials of Varisolve (polidocanol endovenous microfoam), from BTG, show endpoints were met with all therapeutic PEM concentrations for patients with Varicose Veins, compared to placebo (p < 0.0001). In VANISH-2, eighty per cent of patients treated with PEM reported a much or moderate improvement of symptoms, as measured with ...

Study shows benefits of high dose treatment with HeartLight (CardioFocus) for patients with AF

New data demonstrates the benefits of high-dose laser ablation using the HeartLight endoscopic ablation system, from CardioFocus, compared to low-dose treatment in patients with Atrial Fibrillation. Using the HeartLight System, investigators in Frankfurt, Germany were able to achieve an acute pulmonary vein isolation (PVI) rate of 89% after an initial visually guided ablation circle and reported a long-term clinical success ...

European Commission approves Xarelto (Bayer) for PE and treatment of recurrent Deep Vein Thrombosis

Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been approved by the European Commission (EC) for the treatment of Pulmonary Embolism (PE) and the prevention of Recurrent Deep Vein Thrombosis (DVT) and PE in adults. This approval makes rivaroxaban the only novel oral anticoagulant approved in this indication in the EU. The approval of rivaroxaban for the treatment of PE and ...

Study suggests probiotic Cardioviva (Micropharma) can help reduce bad cholesterol in blood

A new study suggests that a probiotic Cardioviva (lactobacillus reuteri), from Micropharma, can lower key cholesterol-bearing molecules in the blood as well as "bad" and total cholesterol in patients with high cholesterol. The study involved 127 adult patients with high cholesterol. About half the participants took L. reuteri NCIMB 30242 twice a day, while the rest were given placebo capsules. ...

Study of Pradaxa (Boehringer) for Atrial Fibrillation shows positive safety profile and efficacy

New data from the RELY-ABLE study have provided additional support to the safety profile and efficacy of Pradaxa (dabigatran etexilate), from Boehringer, for stroke prevention in patients with nonvalvular Atrial Fibrillation (AF) over a period in excess of 2 years. The international multi-centre RELY-ABLE study followed 5,851 patients on dabigatran etexilate for a further 28 months after completion of the ...

Boston Scientific acquires Vessix Vascular and its renal denervation system for Hypertension

Boston Scientific has acquired Vessix Vascular and with it the Vessix V2 Renal Denervation System for the treatment of Hypertension.Renal denervation is a new percutaneous catheter-based procedure that disrupts renal sympathetic nerves whose hyperactivity leads to abnormally high blood pressure. The Vassix system now has CE Mark approval and is approved in Australia...

FREEDOM study finds that CABG has better outcomes than PCI in diabetic patients with Coronary Disease

The FREEDOM study of 1900 patients over 5 years was funded by the National Heart,Lung and Blood Institute and found that for patients with diabetes and advanced coronary disease, coronary bypass surgery grafting (CABG) has a better outcome than percutaneous coronary intervention (with stents) (PCI).After five years, the CABG group had a lower combined rate of strokes, heart attacks, and ...

RELAX-AF trial positive for serelaxin (Novartis) for Acute Heart Failure

RELAX-AF was a randomized, double-blind study involving 1,161 patients and was designed to compare the efficacy and safety profile of RLX030, from Novartis, to placebo in addition to standard therapy for the treatment of Acute Heart Failure (AHF). RLX 030 was given upon hospitalization in the form of an intravenous infusion (30 mcg per kg per day) for 48 ...

Positive results comparing programming of S-ICD and CRT-D defibrillators (Boston Scientific) in patients at risk of Cardiac Arrest

New results from the MADIT-RIT clinical trial demonstrated improved programming of Boston Scientific dual-chamber implantable cardioverter defibrillator (S-ICD) or cardiac resynchronization therapy defibrillator (CRT-D) heart devices can reduce inappropriate therapy and risk of death. MADIT-RIT is a prospective randomized three-arm trial comparing conventional programming with two alternative settings: a high-rate therapy arm and a duration-delay arm. It evaluated 1,500 primary ...

Positive results in Phase III study of lomitapide (Aegerion Pharmaceuticals) for Homozygous Familial Hypercholesterolemia

New results from a Phase III clinical trial of lomitapide, from Aegerion Pharmaceuticals, show it substantially and stably reduced LDL cholesterol in patients with the orphan disease Homozygous Familial Hypercholesterolemia (HoFH). Twenty-nine adult HoFH patients from across the world were enrolled, with 23 patients completing both the efficacy and the safety phases. All of the patients received lomitapide along with ...

AMG 145 (Amgen) success in RUTHERFORD study for HeFH

Amgen has announced that treatment with AMG 145 in combination with statin therapy, with or without ezetimibe, resulted in a reduction in low density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, by up to 56 percent in patients with heterozygous familial hypercholesterolemia (HeFH) in the Phase II RUTHERFORD study.

AMG 145 is an investigational fully human monoclonal antibody directed against PCSK9, ...

AMG 134 success in GAUSS study in patients intolerant of statins

Amgen has announced positive results from the AMG 145 Phase II GAUSS study, in patients with high cholesterol who cannot tolerate statins. Reductions of up to 51 percent were observed in low density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, with AMG 145 and 63 percent with the combination of AMG 145 and ezetimibe, compared to 15 percent with ezetimibe alone. ...

Epanova (Omthera Pharma) successes in EVOLVE and ESPIRIT trials for Dyslipidaemia

Omthera Pharmaceuticals, announced that Phase III results from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) and ESPRIT (Epanova combined with a Statin in Patients with HypertrRglycerIdemia to Reduce Non-HDL CholesTerol) clinical trials for Epanova met all primary and secondary endpoints. Highlights: • Epanova significantly lowers triglycerides (TG) and reduces Non-HDL-C, widely believed to be the most accurate predictor ...

FDA and EU approve Sensation Plus (Maquet Cardiovascular) for patients with Heart Failure

Maquet Cardiovascular has received 510(k) clearance from the FDA and CE mark approval in the EU for its new Sensation Plus 40cc intra-aortic balloon (IAB) catheter. IAB therapy is used in patients with left ventricular failure and other cardiac conditions to augment coronary blood flow and to increase myocardial oxygen supply and decrease myocardial oxygen demand. This new larger-volume, fiber-optic ...

Study shows second generation drug-eluting stents are safe and effective

A study found that second-generation drug-eluting stents are safe and effective in the treatment of left main coronary artery lesions. The ISAR-LEFT MAIN 2 trial is the first and largest multicenter comparison trial between second-generation zotarolimus-eluting (ZES) and everolimus-eluting stents (EES) in invasive treatment of unprotected left main coronary artery (uLMCA) lesions.

The incidence of major adverse cardiac events (MACE) ...

FDA approves Affinity Pixie Oxygenation System (Medtronic Inc) for use in Heart Surgery on children

The FDA have given 510(k) clearance for the Affinity Pixie Oxygenation System, from Medtronic Inc, for use during lifesaving open-heart (cardiopulmonary bypass) surgeries in neonates, infants and small children, including those with congenital heart defects. The Affinity Pixie Oxygenation System serves as a child’s lungs during open-heart surgery by removing carbon dioxide and adding oxygen to the child’s blood before ...

Sideguard coronary stent success in Coronary Bifurcation Disease

Cappella Medical Devices Ltd a company developing solutions for the treatment of Coronary Bifurcation Disease, has announced the multicenter long term follow up results for its innovative Sideguard coronary sidebranch stent . Long term follow up data on the Sideguard stent was obtained from 399 patients from the United Kingdom, Germany, and Italy. The MACE rate was: 3.7% (30 ...

Positive results for Phase III trial of BAY 63-2521 (Bayer HealthCare) in patients with CTEPH

Data from the Phase III CHEST-1 trial evaluating BAY 63-2521 (riociguat), from Bayer HealthCare, in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery showed the study met its primary endpoint by demonstrating a statistically significant improvement in the six-minute walk distance. In the CHEST-1 study, 261 patients with inoperable CTEPH ...

Oral Treprostinal (United Therapeutics) attracts Complete Response Letter from FDA

A Complete Response Letter was received by United Therapeutics from the FDA declining to approve its new drug application (NDA) for treprostinil diethanolamine extended release tablets (oral treprostinil) for the treatment of Pulmonary Arterial Hypertension (PAH).

The FDA letter questioned the clinical importance of the 6 Minute Walk Distance (6MWD) effect size shown in the FREEDOM-M study, the ...

Actelion files Opsumit at FDA for treatment of PAH

Actelion has announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for macitentan Opsumit (macitentan)for the treatment of patients with Pulmonary Arterial Hypertension.

Macitentan, a novel oral dual endothelin receptor antagonist, was studied in the pivotal, long-term, event-driven Phase III outcome study, SERAPHIN, in which 742 patients suffering from pulmonary arterial hypertension ...

Phase III trial of BAY 63-2521 (Bayer HealthCare) for PAH meets primary endpoint

The Phase III PATENT-1 Pulmonary Arterial Hypertension (PAH) trial evaluating BAY 63-2521 (riociguat), from Bayer HealthCare, in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid has met its primary endpoint. PATENT is an international program with active centers in 32 countries. It includes a randomized, double-blind, placebo-controlled trial phase (PATENT-1) ...

CHMP recommends Xarelto (Bayer) for the treatment of Pulmonary Embolism and the prevention of recurrent Deep Vein Thrombosis and Pulmonary Embolism in adults.

Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. The decision of the European Commission on the approval is expected before the year-end. The CHMP recommendation to ...

FDA Advisory Committee recommends lomitapide (Aegerion Pharma) for HoFH

In a 13-2 vote, the FDA Endocrinologic and Metabolic Drugs Advisory considered that Aegerion Pharma provided sufficient efficacy and safety data to support marketing of lomitapide for Homozygous Familial Hypercholesterolemia (HoFH), despite its association with liver toxicity. The application was based on a single 18-month open-label, single-arm pivotal Phase III trial, which only enrolled 29 patients with HoFH, with supportive ...

Sub Analysis of Eliquis (BMS/Pfizer)in ARISTOTLE trial show consistent reductions in Stroke and bleeding risk

The reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis (apixaban) from BMS/Pfizer ,compared to warfarin in the ARISTOTLE trial were consistent across a wide range of stroke and bleeding risk scores in patients with nonvalvular atrial fibrillation. These results of a subanalysis from the ARISTOTLE trial were published today in The Lancet.The subanalysis demonstrated ...

Absorb, the bioresorbable vascular scaffold (Abbott Vascular) available in EU, Latin America and Asia

Abbott has announced that Absorb, the world's first drug eluting bioresorbable vascular scaffold (BVS), is now widely available across Europe and parts of Asia Pacific and Latin America. Absorb is a first-of-its-kind device for the treatment of Coronary Artery Disease (CAD). It works by restoring blood flow to the heart similar to a metallic stent, but then dissolves into the ...

FDA approve S-ICD (Boston Scientific) for sudden Cardiac Arrest

The FDA had given approval for the S-ICD System (Boston Scientific), making it the first commercially available subcutaneous implantable defibrillator for the treatment of patients at risk for sudden Cardiac Arrest. FDA approval of the S-ICD System was based on data from a 330-patient, prospective, non-randomized, multicenter clinical study, which evaluated the safety and effectiveness of the system in patients ...

Generic Diovan HCT launched in USA

The US patent on Diovan (valsartan) and the combination product Diovan HCT (valsartan plus the diuretic hydrochlorothiazide) from Novartis has expired. Mylan has launched its generic version of Diovan HCT and Sandoz (the genetics division of Novartis) has launched an authorised generic version of Diovan HCT. No generic version of Diovan monotherapy is yet available in the US....

Merck returns all rights to vernakalant to Cardiome Pharma for Atrial Fibrillation

Merck & Co has returned the global marketing and development rights to Cardiome Pharma Corporation for both the intravenous and oral formulations for the anti-arrhythmic , Brinavess (vernakalant). Merck has been marketing the intravenous form of the drug, as Brinavess, in the European Union and Latin America for the rapid conversion of recent onset Atrial Fibrillation and planned to launch ...

FDA approves Eylea (Regeneron) for Macular Oedema following Central Retinal Vein Occlusion

The FDA has approved Eylea (aflibercept) Injection, from Regeneron, for the treatment of Macular Oedema following Central Retinal Vein Occlusion (CRVO). The recommended dose for Eylea is 2 milligrams (mg) every 4 weeks (monthly). The approval of Eylea for Macular Oedema following CRVO was based on data from the Phase III COPERNICUS and GALILEO studies.

In both studies, the ...

CHMP recommends Eliquis (BMS/Pfizer) for Prevention of Stroke and Systemic Embolism in NVAF patients

BMS and Pfizer have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Eliquis (apixaban) be granted approval for the Prevention of Stroke and Systemic Embolism in adult patients with nonvalvular atrial fibrillation (NVAF) and one or more risk factors for stroke The positive ...

Assessment finds some benefit of Eliquis (BMS/Pfizer) in patients with hip replacements

The German Institute for Quality and Efficiency in Health Care (IQWiG) has carried out an early benefit assessment of Eliquis (apixaban), from BMS/Pfizer, to detect any added benefits after operations to replace a hip or knee joint. Its studies showed that apixaban was more effective in preventing symptomatic Deep Vein Thrombosis than the comparator therapy: about one in 1000 patients ...

Impella CP heart pump (Abiomed Inc,) receives 510(k) clearance in USA

Abiomed, Inc., announced it has received 510(k) clearance from the FDA for a new percutaneous, catheter-based Impella device providing peak flows of approximately four liters of blood per minute. The increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5. This new heart pump will be marketed as the Impella CP (Cardiac ...

Janssen responds to FDA Complete Response Letter for Xarelto for Acute Coronary Syndrome

Janssen Research & Development, LLC has submitted its reply to the Complete Response Letter from the FDA for the use of Xarelto (rivaroxaban) 2.5 mg twice daily in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS). The submission includes the information requested by the FDA in its letter ...

Positive results for Edarbyclor (Takeda) in Phase III study of Hypertension

Results of a 10-week, Phase III study of Edarbyclor (azilsartan medoxomil and chlorthalidone), from Takeda, for patients with Hypertension found the clinic systolic blood pressure (SBP) reductions for Edarbyclor were significantly greater at six and ten weeks than those of azilsartan medoxomil co-administered with hydrochlorothiazide. Data also showed that more patients achieved their target blood pressure levels when taking the ...

Results show benefits of RX Herculink Elite Stent (Abbott Vascular) in patients with Renal Artery Stenosis

Results from the HERCULES trial evaluating the safety and effectiveness of the RX Herculink Elite Stent, from Abbott Vascular, found that Renal Artery Stenosis patients with higher blood pressure levels at baseline had the most dramatic reduction in blood pressure following intervention. At the start of the trial the mean systolic blood pressure of the trial group was 162 mm ...

Aspirin-clopidogrel no better than aspirin alone for patients with Lacunar Stroke

Aspirin combined with the antiplatelet drug clopidogrel is no better than aspirin alone for stroke prevention in people with a history of lacunar strokes, and the combination carries a greater risk of gastrointestinal bleeding, according to results of a trial funded by the National Institutes of Health. Lacunar strokes occur due to chronic high blood pressure and typically produce small ...

Aquilion CT scanner (Toshiba) accurately assess coronary blockages

The Toshiba Aquilion 320-detector computed tomography (CT) scanner can accurately sort out which people with chest pain need or don't need an invasive procedure such as cardiac angioplasty or bypass surgery to restore blood flow to the heart, according to an international study. The CORE 320 study is the first prospective, multicenter study to examine the diagnostic accuracy of high ...

Xarelto(Bayer/Janssen) sub group analysis of TIMI trial shows reduction in mortality for ACS patients

A major subgroup analysis from the ATLAS ACS 2-TIMI 51 study of 7,817 patients with ACS and a recent ST-segment elevation myocardial infarction (STEMI) demonstrated that oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily, from Bayer/Janssen, when added to standard antiplatelet therapy, provides a significant mortality benefit. The analysis showed that adding rivaroxaban to standard antiplatelet therapy significantly reduced the ...

Positive results from study of PressureWire (St Jude Medical) in PCI patients

Results of the FAME II Trial demonstrate patients with FFR-guided stenting that use PressureWire (technology used to measure blood flow restriction in the coronary arteries), from St Jude Medical, plus the best available medical therapy had superior outcomes to those treated with medical therapy alone. Results revealed this yielded an 86 percent relative risk reduction for unplanned re-admission to the ...

Positive results in trial of Solitaire (Covidien) for blood flow restoration

The Solitaire Flow Restoration Device for opening blocked arteries, from Covidien, performs better than a conventional device, according to new results from the SWIFT trial which have been published in The Lancet.

In the double-blind, randomised trial of 113 patients, the researchers compared the performance of the Solitaire device to the Merci retriever. Patient outcomes were significantly improved in the ...

TRILOGY ACS study results for Efient/Effient (Daiichi Sankyo/Eli Lilly)

Daiichi Sankyo Company, Limited and Eli Lilly and Company have announced data from the TRILOGY ACS study, a phase III trial comparing Effient/Efient (prasugrel) plus aspirin to clopidogrel plus aspirin in patients with unstable angina (UA) or non-ST elevation myocardial infarction (NSTEMI), who were managed medically without an artery-opening procedure. At 30 months, 13.9 percent of prasugrel patients versus 16.0 ...

Two new Phase III studies of Xarelto (Bayer HealthCare) initiated for AF patients scheduled for surgery

Bayer HealthCare has initiated two new studies investigating Xarelto (rivaroxaban) in patients with Atrial Fibrillation who are scheduled for cardioversion or first catheter ablation. X-VeRT is the largest randomised study dedicated to evaluating patients with AF scheduled for cardioversion. It will include approximately 1,500 patients across 17 countries worldwide, including the UK. The study will further examine the efficacy and ...

Watchman LAAC device (Boston Scientific) receives expanded CE indication

European regulators have approved an expanded indication for the Boston Scientific Watchman Left Atrial Appendage (LAA) Closure Device. The new indication offers patients with atrial fibrillation (AF), and a contraindication to warfarin and the newer oral anticoagulants, a new treatment option for Stroke Reduction.

Patients in AF have an increased risk of stroke due to the migration of clots ...

LCZ 696 success in study for Heart Failure with preserved ejection fraction

The Phase II PARAMOUNT study showed that the investigational compound LCZ 696 (Novartis) is the first therapy to significantly reduce a key predictor of morbidity and mortality in patients with a condition called heart failure with preserved ejection fraction (HF-PEF). This difficult-to-treat disease affects up to half of the 20 million people with heart failure in Europe and the US ...

Xience Xpedition everolimus stent (Abbott Vascular) receives CE Mark

The Xience Xpedition Everolimus Eluting Coronary Stent System received CE Mark in Europe for the treatment of Coronary Artery Disease. Abbott Vascular is launching the product immediately in CE Mark countries. Xience Xpedition features a new stent delivery system designed to optimize acute performance, particularly in challenging coronary anatomies. Xience Xpedition is supported by the robust clinical evidence of the ...

Delay in review of QT 1571(Novartis) for PAH

The FDA postponed a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review QT 1571 which is imatinib (Gleevec/Glivec in its cancer indication) from Novartis for Pulmonary Arterial Hypertension. Novartis has decided to withdraw the NDA to allow time to produce more information for the FDA...

FDA approve Trevo Pro Retriever (Stryker) for clot removal

The Trevo Pro Retriever, from Stryker, has been granted 510(k) market clearance by the FDA for clot removal. Approval is based on clinical results from the TREVO 2 clinical trial presented at the 2012 European Stroke Conference in May. This technology demonstrated the highest rate of revascularization in a randomized embolectomy stroke device trial, and achieved significantly better post-procedure revascularization ...

FDA approves GeNOsyl MV-1000 (GeNo LLC) for neonates

GeNo LLC has received clearance from the FDA to market its inhaled nitric oxide (NO) delivery system GeNOsyl MV-1000. The target patient population is controlled by the drug labeling for FDA-approved NO which is currently neonates. The GeNOsyl MV-1000 is intended to be used in hospital settings including the NICU and intra-hospital transport settings. The GeNOsyl MV-1000 injects a constant ...

FDA approves CorPath 200 (Corindus Inc) robotic-assisted system for PCI

The FDA has given 510(k) clearance for the CorPath 200 System, from Corindus Inc, to be used in Percutaneous Coronary Interventions (PCI). The technology is now approved in the US to assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in patients with Coronary Artery Disease (CAD).

The CorPath PRECISE Trial—a prospective, single-arm, ...

AutoRIC (CellAegis) receives CE mark for AMI patients

CellAegis has received a CE Mark for its autoRIC device, which allows simple automation of remote ischemic conditioning (RIC) at the point of care for patients with Acute Myocardial Infarction. CellAegis' autoRIC Device has been developed for acute care applications in the ambulance, emergency room and other hospital settings, or for chronic treatment in the home. Remote ischemic conditioning uses ...

Brilinta/Brilique(AstraZeneca) study in Peripheral Vascular Disease

Astra Zeneca will commence a new study called EUCLID of Brilinta/Brilique(ticagrelor) to compare twice daily dosing of Brilinta/Brilique with once dosing daily of now generic Plavix (clopidogrel) in 11 500 patients with Peripheral Vascular Disease....

Update recommends Brilinta (AstraZeneca) for Heart Attack patients

Brilinta/Brilique (ticagrelor), from AstraZeneca, should be considered along with older blood thinners clopidogrel and prasugrel for treating patients who are experiencing chest pain or some Heart Attacks, according to joint updated guidelines issued by the American Heart Association (AHA) Task Force on Practice Guidelines and the American College of Cardiology (ACCF) Foundation.

The “focused update” on unstable angina ...

Trial finds that Brilinta / Brilique (AstraZeneca) is cost effective for Acute Coronary Syndrome patients

Full data results of the PLATO health economics substudy, which have been published online in the European Heart Journal, demonstrate that even at a higher drug cost and incremental cost per Acute Coronary Syndrome (ACS) patient, Brilinta / Brilique (ticagrelor), from AstraZeneca, numerically lowered non-drug healthcare costs versus generic clopidogrel and is cost-effective. The analysis used in the health economics ...

FDA issues Complete Response Letter for Eliquis (BMS/Pfizer) in Stroke Prevention

The FDA has issued a Complete Response Letter regarding the New Drug Application for Eliquis (apixaban) from BMS/Pfizer for the Prevention of Stroke and Systemic Embolism in patients with nonvalvular atrial fibrillation. The FDA requests additional information on data management and verification from the ARISTOTLE trial. BMS and Pfizer will work closely with the FDA on the appropriate next steps ...

VEN 309 (Vetrus Biosciences) fails Phase III for treatment of Haemorrhoids

Ventrus Biosciences, Inc. has reported that its Phase III, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with Haemorrhoidal Disease did not meet its endpoints.The Company will analyze the Phase III data further but believes that its efforts will be better allocated toward the planned completion of its VEN 307 (diltiazem cream) development program in anal fissures ...

FDA refuses to recommend semuloparin (Sanofi) for prevention of VTE

The FDA's Oncologic Drugs Advisory Committee voted 14 to 1 not to recommend approval of semuloparin, from Sanofi, for the prevention of Venous Thromboembolism (VTE) in patients receiving chemotherapy for metastatic Lung or Pancreatic Cancer. The committee also rejected its use in patients with advanced solid tumours with a VTE risk score greater than or equal to three. The submission ...

FDA issues Complete Response Letter relating to Xarelto (Bayer/Janssen Pharma) for Acute Coronary Syndrome

Bayer HealthCare announced that the FDA has issued a Complete Response Letter regarding the supplemental New Drug Application (sNDA) for the oral anticoagulant Xarelto (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy for the reduction of secondary cardiovascular events (cardiovascular death, myocardial infarction or stroke) in patients with Acute Coronary Syndrome (ACS). Bayer is evaluating the Complete Response ...

NOP 47 significant impact on Vascular Endothelial function

Whey protein intake reduces CVD risk, but little is known whether whey-derived bioactive peptides regulate vascular endothelial function (VEF). Researchers determined the impact of a whey-derived extract (NOP-47) from Glanbia Nutrition on VEF in individuals with an increased cardiovascular risk profile. Men and women with impaired brachial artery flow-mediated dilation (FMD) (n 21, age 55 (sem 1·3) years, BMI 27·8 ...

Sub-analysis of RE-LY trial shows Pradaxa (Boehringer) similar to warfarin in Atrial Fibrillation patients undergoing surgery

A new retrospective sub-analysis of the RE-LY trial for Pradaxa (dabigatran etexilate), from Boehringer, vs warfarin suggested similar rates of peri-procedural bleeding and thromboembolic complications, such as a Stroke or systemic embolism, in non-valvular Atrial Fibrillation (NVAF) patients undergoing a surgical or invasive procedure. A total of 4,591 out of 18,113 patients in the trial had anti-coagulant therapy interrupted at ...

Phase III study of Edarbyclor (Takeda) shows positive results for Hypertension

Results of a 12-week, head-to-head, Phase III study found systolic blood pressure (SBP) reductions of Edarbyclor (azilsartan medoxomil and chlorthalidone), from Takeda, were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide in patients with Hypertension. Results after 12 weeks of treatment showed that the fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg reduced clinic SBP by ...

Intergard Synergy vascular graft (Maquet Cardiovascular) receives CE mark

Maquet Cardiovascular has received the CE mark for its Intergard Synergy vascular graft. This graft combines the antimicrobial properties of silver acetate and triclosan. Vascular graft infection, although rare, is one of the most serious complications of vascular reconstructive surgery and in vitro testing of the Intergard Synergy vascular graft demonstrates antimicrobial efficacy against a broad spectrum of micro-organisms including ...

Semuloparin (Sanofi) may need more data for FDA approval for prophylaxis of VTE

Semuloparin, a low molecular weight heparin from Sanofi ,is filed at the FDA for the prophylaxis of venous thromboembolism in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors. FDA regulators have commented that the application does not have enough data to support its approval for that use. The ...

Study shows positive results with HeartLight EAS (CardioFocus) for Atrial Fibrillation

A new study demonstrates high acute success (98%) and durable pulmonary vein (PV) isolation rates in the treatment of Atrial Fibrillation, using the HeartLight EAS ablation system, from CardioFocus. HeartLight Endoscopic Ablation System incorporates an illuminating endoscope to provide physicians with direct visualization within a beating heart, in real time and without radiation. To determine durability, the study involved a ...

Prescribing update to Pradaxa (Boehringer) for Stroke Prevention (AF) patients

Prescribing information for Pradaxa (dabigatran etexilate) capsules, from Boehringer, has been updated to affirm that "Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." The update to the Clinical Studies section is based on the results of the pivotal RE-LY trial conducted in 18,000 patients with non-valvular atrial fibrillation (NVAF). In the RE-LY trial, ...

NICE recommends Xarelto for DVT and PE

In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) recommends the use of Xarelto (rivaroxaban) from Bayer HealthCare as an option for treating deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism in adults diagnosed with acute DVT....

FDA approves two new lengths of the Promus Element stent system (Boston Scientific)

The FDA has approved the 32 mm and 38 mm lengths for the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, from Boston Scientific. The Promus Element Plus Stent System is now available in a matrix of 94 sizes, ranging in diameter from 2.25 mm to 4.00 mm and lengths of 8 mm to 38 mm on both Monorail ...

FDA Advisory Committee rejects Xarelto for Acute Coronary Syndrome

The Cardiovascular and Renal Drugs Advisory Committee voted 6-4 (with one abstention) against the approval of Xarelto (rivaroxaban) 2.5 mg BID from Johnson & Johnson/Bayer HealthCare, in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome). The FDA is not bound to follow the panel's advice, although it usually does, ...

Positive results for Carillon Mitral Contour System (Cardiac Dimensions) for Heart Surgery

New results of the TITAN trial of the Carillon Mitral Contour System, from Cardiac Dimensions, show that implanted patients demonstrated significant reductions in functional mitral regurgitation (FMR) as assessed by multiple quantitative measures, including regurgitant volume, which decreased from 34.5 to 17.4 ml through 12 months (p<0.001). Additionally, patients experienced significant reverse remodeling with left ventricular diastolic and systolic volumes ...

Passeo-18 Lux Balloon study success with femoropopliteal lesions

Six-month results from the BIOLUX P-I study, demonstrating excellent safety and efficacy results for the Biotronik Passeo-18 Lux Paclitaxel Releasing Balloon, were presented on Thursday, May 17, 2012, at the EuroPCR 2012 congress by Dr. Andrej Schmidt, Chief Angiologist at Herzzentrum/Park- Krankenhaus, Leipzig, Germany.The Passeo-18 Lux Paclitaxel Releasing Balloon is a novel approach for treating de novo and restenotic femoropopliteal ...

Positive two-year results in study of Promus Element Cardiac Stent (Boston Scientific)

Two-year results from the PLATINUM Small Vessel study demonstrate that the 2.25 mm Promus Element (Everolimus-Eluting) Platinum Chromium Cardiac Stent System, from Boston Scientific, shows positive safety and effectiveness outcomes in treating de novo coronary lesions in small coronary vessels. The PLATINUM study met its primary endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4 ...

FDA approves generic Plavix

The FDA has approved on 17 My 2012 generic versions of Plavix (clopidogrel) for Dr Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals for 300 milligram (mg) clopidogrel. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel....

FDA approves Epic Nitinol Stent (Boston Scientific) for Iliac Artery Disease

oston Scientific announced FDA approval and market launch of the Epic Vascular Self-Expanding Stent System. The Epic Stent is designed to open blocked arteries in patients with iliac artery stenosis, a form of peripheral vascular disease associated with severe leg pain caused by insufficient blood flow. The Epic Stent is a self-expanding Nitinol stent designed to sustain vessel patency, while ...

Positive data from EVOLVE trial of Synergy Cardiac Stent system (Boston Scientific)

Data from the EVOLVE trial shows the Synergy everolimus-eluting Coronary Stent system, from Boston Scientific, demonstrated non-inferior results in treating de novo coronary artery lesions at one year compared to the Promus Element everolimus-eluting stent system. The trial reported one-year clinical and six-month intravascular ultrasound (IVUS) outcomes data, evaluating the safety and effectiveness of the Synergy stent. Data demonstrated that ...

Study shows CorPath 200 robotic PCI surgery system (Corindus Inc) is safe and practical

The CorPath 200 robotic system, from Corindus Inc, can safely assist surgeons in performing Percutaneous Coronary Interventions (PCI) while significantly reducing the physician's exposure to radiation and improving precision and control, according to results of the PRECISE study. The CorPath 200 System consists of a robotic drive and single-use cassette mounted on an articulating arm attached to the cath lab ...

Success For Watchman LAAC device ( Boston Scientific) in Stroke Prevention

Results were announced by Boston Scientic from the ASA Plavix (ASAP) Study, which studied the Watchman Left Atrial Appendage Closure (LAAC) device. The data showed a reduction in the risk of ischemic stroke by 75 percent in patients with atrial fibrillation who have a contraindication to oral anticoagulants such as warfarin.The prospective multi-center ASAP Study evaluated 150 patients with contraindications ...

FDA approves Paradym defibrillators (Sorin) for patients at risk of Cardiac Arrest

The FDA has approved the Paradym RF family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices, from Sorin, for patients at risk of sudden Cardiac Arrest, including some whose heart failure can be managed by cardiac resynchronization therapy. These new heart devices, including the single-chamber Paradym RF VR, the dual-chamber Paradym RF DR and the Paradym RF ...

Janssen files Xarelto at FDA for Venous Thromboembolism and ACS

Janssen Research & Development, a Johnson & Johnson subsidiary, has filed at the FDA for approval of Xarelto (rivaroxaban) as a treatment for Deep Vein Thrombosis and Pulmonary Embolism, and as a preventative treatment for recurring Venous Thromboembolism. Deep Vein Thrombosis is a blood clot in large veins, usually in the legs. Those blood clots sometimes dislodge and travel to ...

Macitentan(Actelion) success in Phase III for PAH

Initial analysis indicates that the pivotal, long-term, event-driven study SERAPHIN with macitentan, a novel dual endothelin receptor antagonist from Actelion, in 742 patients suffering from Pulmonary Arterial Hypertension (PAH) and treated for up to three and a half years, has met its primary endpoint. SERAPHIN is the largest randomized, controlled study in PAH patients with a long-term treatment to include ...

Study shows Stroke risk high when Xarelto (Bayer HealthCare) stopped

Patients with irregular heartbeats who are taken off anti-clotting medication Xarelto (rivaroxaban), from Bayer HealthCare, face a high risk of Stroke within a month. Researchers analyzed data from the Phase III ROCKET AF trial following concerns about possible increased rates of Stroke and blood clots after discontinuing Xarelto. They found strokes and blood clots occurred at similar rates with either ...

AstraZeneva and The Medicines Company to co-promote Brilinta in USA

AstraZeneca and The Medicines Company have announced a global collaboration for their acute ischaemic heart disease compounds. The first part of this collaboration is a US co-promotion for AstraZeneca’s oral antiplatelet medicine Brilinta (ticagrelor).Under the terms of the co-promotion agreement, The Medicines Company sales force will begin supporting Brilinta in May 2012. This will complement the AstraZeneca sales team’s promotion ...

Aliskiren (Novartis)availability terms agreed with FDA

Novartis announced that the Tekturna labels have been updated in the USA, following the FDA review of the preliminary findings from the ALTITUDE study.The label change includes a contraindication against combined use of aliskiren-based products with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in patients with diabetes. The FDA has also requested the inclusion of a warning ...

Igaki-Tamai biodegradable stent (Kyoto Medical Planning) safe for long-term treatment of Coronary Artery Disease

The Igaki-Tamai biodegradable stent, from Kyoto Medical Planning, proved safe when implanted in humans with Coronary Artery Disease (CAD) over a 10-year study, a new study shows. The stent is already used in nine European Union countries and Turkey — but not in the US — to treat Peripheral Artery Disease (PAD), the disorder which results from fatty deposits that ...

Endurant AAA Stent Graft System(Medtronic) two year results

Medtronic Inc.has announced the two-year results from its U.S. clinical study of the Endurant AAA Stent Graft System for Abdominal Aortic Anuerysm. Presented at this year's Charing Cross International Symposium in London, the prospective Endurant U.S. investigational device exemption (IDE) study's complete results at two years continue to demonstrate durable clinical performance with strong safety and efficacy in long-term follow-up. ...

FDA extends approval of Total Artificial Heart (Syncardia)to be used in destination therapy

SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has announced that the FDA has approved a Humanitarian Use Device (HUD) designation for the SynCardia temporary Total Artificial Heart to be used for destination therapy in addition to its current PMA approval as a bridge to transplant.The FDA approval ...

Arrow VPS System(Teleflex) received CE Mark approval for catheter positioning

Teleflex Inc., announced that its VasoNova Inc. subsidiary has been issued CE certification from the British Standards Institution to market the company's Arrow VPS system to the European Union. The Arrow VPS system is the first to use a unique micro-Doppler ultrasound technology in combination with intravascular ECG and advanced algorithms to provide precise guidance to clinicians and enable correct ...

NICE recommends Xarelto (Bayer) for Stroke Prevention

NICE (The National Institute for Health and Clinical Excellence) has recommended Xarelto (rivaroxaban) from Bayer Healthcare in a final draft guidance as an option for the Prevention of Stroke and Systemic Embolism in people with atrial fibrillation. NICE revised its original decision not to recommend Xarelto after Bayer supplied requested additional evidence on the clinical and cost effectiveness of the ...

Positive results for Xarelto (Bayer/Janssen) in PE and VTE

The results of the Phase III EINSTEIN-PE 4,833-patient study have been presented at the American College of Cardiology meeting in Chicago which show that Xarelto (rivaroxaban) from Bayer/Janssen was as effective and safe as the current dual drug approach of subcutaneous Lovenox (enoxaparin), followed by warfarin, in treating patients with acute symptomatic pulmonary embolism (PE) and preventing them from developing ...

Positive results for the ClearWay RX Infusion Catheter (Atrium) for PCI

Results of the INFUSE-AMI study demonstrated that in patients with large anterior STEMI presenting early after symptom onset and undergoing Percutaneous Coronary Intervention (PCI), intracoronary administration of the platelet inhibitor abciximab delivered directly to the Heart Attack lesion site via Atrium's ClearWay RX Local Therapeutic Infusion Catheter significantly reduced the size of the MI at 30 days (primary endpoint). The ...

Resolute DES (Medtronic) delivers clinical benefits out to two years

The Resolute drug-eluting stent (DES), from Medtronic, maintains a powerful and persistent treatment effect for a wide variety of patients with Coronary Artery Disease, including those with Diabetes. A new study that includes 2 years of follow-up, the RESOLUTE US clinical study and two pooled analyses of the entire Resolute clinical program –– one on safety measures for all patients ...

Vorapaxar (Merck) plus standard of care significantly reduces risk of Cardiovascular Events

Top-line results of the TRA-2P study of vorapaxar, from Merck, showed that the addition of vorapaxar to standard of care (e.g. aspirin, or thienopyridine or both) resulted in a significant reduction in the risk of the composite of cardiovascular (CV) death, heart attack, stroke or urgent coronary revascularization by 12 percent compared to placebo. This is the first time that ...

Merck inc withdraws from oral vernakalant collaboration

Merck Inc., ceases development of the oral formulation of anti arrhythmic vernakalant which it has licensed from Cardiome Pharma of Canada. The oral drug was being developed for long term prevention of atrial fibrillation recurrence. Merck Inc.,was influenced by its view of the regulatory environment and projected development timelines. Meck Inc., already markets the i.v. formulation as Brinavess in the ...

CRTX 080 (Cornerstone) is filed at FDA for Hyponatraemia

FDA has accepted the new drug application for the investigational Hyponatraemia treatment CRTX 080, from Cornerstone Therapeutics CRTX 080 is a highly potent oral non-peptide, which acts on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes. Hyponatremia is a metabolic condition that occurs when there is not enough sodium in ...

Signifor(Novartis) success in Phase III Cushings Disease trial

Signifor (pasireotide)from Novartis, significantly reduced urinary cortisol levels and improved symptoms of Cushing's disease in the largest clinical study of this endocrine disorder ever conducted. Results of the clinical trial conducted at centers on four continents appear in the March 8 New England Journal of Medicine and show that treatment with pasireotide cut cortisol secretion an average of 50 percent ...

Surfaxin (Discovery Labs) is FDA approved for Respiratory Distress Syndrome

The FDA has approved Surfaxin (lucinactant) from Discovery Laboratories for the prevention of Respiratory Distress Syndrome (RDS), a breathing disorder that affects premature infants.The lungs of premature infants are not able to make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse and the infant has ...

GSK files at FDA for H5N1 subtype Influenza vaccine

GSK has submitted a regulatory application to the FDA seeking approval for an H5N1 influenza vaccine. The Biologics License Application seeks approval for the “active immunisation for the prevention of disease in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine” for use as directed by ...

Positive results for NA-1 (NoNo) in Phase II Trial of Stroke patients

Final results of the ENACT Phase II clinical trial of the drug, NA-1 (TAT-NR2B9c) for reducing Stroke damage, from NoNo Inc, have been presented. The ENACT trial was a 185-patient, randomized, double-blind placebo-controlled study performed to assess the safety and efficacy of NA-1 in reducing small embolic strokes in patients that underwent an endovascular repair of intracranial Aneurysms. Patients enrolled ...

Baxter initiates Phase III stem cell therapy trial for Chronic Myocardial Ischaemiad

Baxter has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individuals own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).The trial will enroll approximately 450 patients across 50 clinical sites in the United States , who will be randomized to one of three arms: treatment ...

FDA approves ION and TAXUS Liberte Drug-Eluting Coronary Stents (Boston Scientific) in Heart Attack patients

The ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System and TAXUS Liberte Paclitaxel-Eluting Coronary Stent System, from Boston Scientific, have received FDA approval for use in patients experiencing an Acute Myocardial Infarction or heart attack. They are the only US drug-eluting stent systems with an approved indication to treat patients with AMI. The new indication, which accounts for approximately 10 percent ...

Trial of Vessix V2 Denervation System (Vessix Vascular) underway for Hypertension patients

Patient treatments have begun in the multi-centre REDUCE-HTN renal denervation clinical study of the Vessix V2 Renal Denervation System, from Vessix Vascular, for patients with uncontrolled Hypertension. REDUCE-HTN is a non-randomized, prospective, single cohort, 64-patient study designed to validate the clinical performance of the Vessix V2 System for medication-resistant Hypertensive patients. Renal denervation is a new percutaneous catheter-based procedure that ...

Regeneron files Eylea(VEGF TRAP-EYE) at FDA for CRVO

Based on the results of the GALILEO study and one otherstudy Regeneron Pharmaceuticals, has submitted a supplemental Biologics License Application (sBLA) in the US for the CRVO indication and has been granted an FDA action date of 23 September 2012....

FDA accepts NDA for oral Remodulin (United Therapeutics) for PAH

The FDA has accepted for review the new drug application (NDA) for oral Remodulin (treprostinil diethanolamine sustained release), from United Therapeutics, for the treatment of Pulmonary Arterial Hypertension. The NDA will be subjected to a standard 10-month review period, with a targeted user fee deadline of October 27, 2012....

FDA approve Resolute Integrity (Medtronic Inc) Drug-Eluting Stent

The FDA has approved the Resolute Integrity Drug-Eluting Stent (DES), from Medtronic Inc, for the treatment of Coronary Artery Disease (CAD). The device’s approval stems from the results of a series of studies of the Resolute DES, which showed consistent clinical performance across a broad spectrum of patients –– including those with Diabetes, a common contributor to Coronary Artery Disease ...

CHMP defines limits of aliskiren (Novartis) in Hypertension

Novartis announced that the CHMP has concluded the risk-benefit review of Rasilez (aliskiren) and combination products containing aliskiren and confirmed it remains positive in the European Union for the treatment of essential Hypertension. In addition, the CHMP has requested an update to the product information of Rasilez® (aliskiren) and combination products containing aliskiren available in the EU. The CHMP has ...

FDA approves trial of Celution System (Cytori Therapeutics) for CMI

Cytori Therapeutics has received an Investigational Device Exemption (IDE) approval from the FDA to begin the ATHENA trial using its Celution System. ATHENA will investigate the use of the Celution System to treat a form of Coronary Heart Disease, Chronic Myocardial Ischemia (CMI). The IDE application was originally submitted to the FDA in December 2011. The trial will enroll up ...

Varisolve (BTG) success in VANISH-2 trial for Varicose Vein treatment

VANISH-2, the first of two US Phase III studies comparing Varisolve (polidocanol endovenous microfilm) from BTG with placebo in patients with symptomatic and visible Varicose Veins and saphenofemoral junction incompetence. The trial met all primary, secondary and tertiary efficacy endpoints....

FDA approves wider indication for fibrin sealant Tisseel (Baxter)

The FDA has approved Tisseel [Fibrin Sealant] from Baxter to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical.TISSEEL mimics the final stages of the body’s own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis....

NICE final guidance positive for Eliquis(BMS/Pfizer)in VTE

NICE, the health technology appraisal body for England and Wales, has published final guidance recommending Eliquis (apixaban) from BMS/Pfizer as an option for preventing venous thromboembolism after knee and hip surgery. Eliquis will compete against Pradaxa from Boehringer abd Xarelto from Bayer HealthCare in this indication. No decision was made as to cost benefit comparisons....

Inferanserin (Ventrus BioSciences) in Phase III for treatment of Haemorrhoids

Ventrus Biosciences Inc. expects to report in June 2012 the results of a pivotal Phase III trial of inferanserin (VEN 309) a highly selective peripheral 5-HT2A receptor antagonist and topical treatment for Haemorrhoids. The Phase III trial is being conducted in 600 patients at 70 centres in the USA and its primary endpoint will be cessation of bleeding by day ...

Cangrelor (AstraZeneca/ The Medicines Company) maintains platelet inhibition and anti-clotting levels prior to Cardiac Surgery

A study shows that cangrelor, from AstraZeneca/The Medicines Company, has the unique properties of achieving very fast blood thinning effects when needed to protect from heart attacks, but also dissipates rapidly so patients can undergo surgery without the excessive bleeding often associated with blood thinning medications. The BRIDGE trial tested the efficacy of this intravenous antiplatelet therapy that allows patients ...

Epic Nitinol Stent success in ORION trial for Iliac Artery Disease

The 125 patient ORION trial of the Epic self-expanding nitinol stent system for Iliac Artery Disease from Boston Scientific, met its primary endpoint, a composite rate of major adverse events (MAE)--including myocardial infarction, target vessel revascularization and amputation--at 9 months. The results exceeded expectations, demonstrating a 9-month MAE rate of 3.4% in the intent-to-treat population--far lower than the goal of ...

Combination treatment with Tekturna/Rasilez (Novartis) raises risk for patients with Hypertension

Following the closure of the Phase III ALTITUDE trial, researchers have published the first detailed figures showing the risk of using Tekturna/Rasilez, from Novartis, in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARB) drugs. After reviewing 10 large trials, researchers found that patients taking Tekturna/Rasilez as well as an ACE inhibitor or ARB had about a ...

Stenting with Emboshield Pro (Abbott Vascular) for Carotid Arteryt Disease becoming safer in high-risk patients

Placing a stent in a key artery in the neck is safer than ever in patients ineligible for the standard surgical treatment of carotid artery disease, according to results from the PROTECT trial designed to examine the safety of Emboshield Pro, from Abbott Vascular. Emboshield Pro is an embolic protection device used in combination with stenting to help enlarge the ...

Pradaxa(Boehringer) risk of Myocardial Infarction and Acute Coronary Syndrome

Pradaxa/Rendix (dabigatran etexilate), from Boehringer, is associated with an increased risk of Myocardial Infarction (MI) or Acute Coronary Syndrome (ACS) in a broad spectrum of patients when tested against some other medicines, according to a study published by the Archives of Internal Medicine. The meta-analysis of 7 studies, with 30,514 participants, Ken Uchino and Adrian V. Hernandez of the Cleveland ...

FDA approves Chocolate PTA Balloon Catheter(TriReme Medical) for PAD

The FDA has given 510(K) clearance to market the Chocolate PTA balloon catheter, from TriReme Medical, for the treatment of occluded Peripheral Artery Disease. Chocolate's novel design incorporates a constraining structure over a semi-compliant balloon to facilitate the formation of small modules or pillows. Through this advanced mechanism of action, Chocolate minimizes shear stress and allows for uniform inflation and ...

Xarelto (Bayer/Janssen) is FDA filed for Acute Coronary Syndrome

Bayer HealtCare and Janssen Pharmaceuticals have submitted a supplemental New Drug Application to the FDA seeking approval for the use of Xarelto (rivaroxaban) to reduce the risk of (thrombotic) cardiovascular events in patients with Acute Coronary Syndrome.The application is based on the ATLAS ACS 2-TIMI 51 study,...

Xareto (J&J/Bayer) is FDA filed for Acute Coronary Syndrome

Johnson & Johnson and Bayer HealthCare submitted a supplemental new drug application to the FDA on 29 December seeking approval to market the oral anticoagulant Xarelto (rivaroxaban) as a therapy to reduce the risk of thrombotic events in patients with Acute Coronary Syndrome. The submission includes data from the pivotal Phase III ATLAS ACS 2 TIMI 51 trial, which showed ...

EU approval is given for intravenous formulation of Remodulin (United Therapeutics)

European approval has been given to United Therapeutics Corp for the intravenous formulation of its prostacyclin vasodilator, Remodulin (treprostinil), to treat Pulmonary Arterial Hypertension (PAH). Twenty two European Union member states have approved the formulation through the French regulatory agency AFSSAPS under the mutual recognition process. United Therapeutics has separately filed in the US for the oral version of Remodulin. ...

Tekturna (Novartis) fails ALTITUDE study in Diabetic Hypertensive patients with Renal Impairment

Tekturna/Rasilez (aliskiren) from Novartis has failed to show a benefit in target organ protection which has resulted in the early closure of the Phase III ALTITUDE study by reason of safety concerns. The 8,606-patient trial was assessing the effects of adding aliskiren to standard antihypertensive treatment in patients with Type 2 Diabetes and RenalImpairment. Researchers found a higher rate of ...

FDA updates label safety warning for Multaq (Sanofi-Aventis)

The FDA adds new safety warnings to the label of Multaq (dronedarone), from Sanofi-Aventis, after studies revealed the drug doubles the rate of cardiovascular death, stroke, and heart failure in patients with permanent Atrial Fibrillation. The revised labelling stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. The ...

FDA approves EXCOR Pediatric System (Berlin Heart) to support Heart Failure patients until a donor is found

The FDA has approved the EXCOR Ventricular Assist Device from Berlin Heart, a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found. This is the first FDA-approved pulsatile mechanical circulatory support device specifically designed for children. The device consists of one or ...

Onduarp (Boehringer) is EMA approved for Essential Hypertension

Onduarp(telmisartan plus amlodipine) from Boehringer has been approved by the EMA for patients whose blood pressure is not adequately controlled by amlodipine alone. Onduarp can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets. The drug is FDA approved as Twynsta....

EU approves Edarbi (Takeda) for Hypertension

The European Commission has approved the once-daily angiotensin receptor blocker (ARB) Edarbi (azilsartan medoxomil) from Takeda for Essential Hypertension. The approval is based on seven Phase III trials involving nearly 6,000 patients where the drug showed its superiority to placebo and the highest approved doses of two commonly-prescribed ARBs, Benicar (olmesartan) from Daiichi Sankyo and Diovan (valsartan)from Novartis. The drug ...

Generic Caduet (Pfizer) launched in USA by Ranbaxy

Ranbaxy has launched in the USA, an authorised generic version of Caduet, the fixed-dose combination of atorvastatin-amlodipine besylate for Hypertension , as part of an agreement between Pfizer and Ranbaxy...

NICE recommends Eliquis (BMS/Pfizer) for Venous Thromboembolism Prevention

The National Institute for Clinical Excellence (NICE) has published final draft guidance recommending Eliquis (apixaban) from BMS/Pfizer as an option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip replacement or total knee replacement surgery/...

FDA accepts for review Eliquis (BMS/Pfizer) for Stroke Prevention associated with Atrial Fibrillation

The FDA has accepted for review a New Drug Application for Eliquis (apixaban) from BMS/Pfizer,an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The FDA accepted the filing and assigned a priority-review designation. The Prescription Drug User Fee Act goal date for a decision by the FDA is March 28, 2012. An application ...

Rasitrio (Novartis) combination is EU approved for Hypertension

Rasitrio, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide in a single pill from Novartis has received approval from the European Commission for the treatment of high blood pressure. The pivotal study supporting the application showed that Rasitrio produced statistically significant blood pressure reductions compared to dual combinations of each of its individual components, including aliskiren/amlodipine 300 mg/10 mg, ...

FDA approves HeliFX Aortic Securement System (Actus Endosystems) for treating aortic endografts

The FDA has given 510(K) approval for the HeliFX Aortic Securement System, from Aptus Endosystems, the first system that can repair a failed or problematic aortic endograft, a fabric tube used to repair a dangerously large Aortic Aneurysm. The HeliFX Aortic Securement System is a cassette of nickel-cobalt corkscrew-shaped staples that is loaded into a long, thin, tube-like delivery catheter. ...

Sevikar HCT (Daiichi Sankyo) now available in the UK

Sevikar HCT (olmesartan medoxomil, amlodipine besylate plus hydrochlorothiazide) from Daiichi Sankyo Europe, the first three-in-one pill to treat Hypertension, has been launched in the UK. Currently around 2 million people in the UK need to take three or more pills daily to treat their hypertension. The drug is approved in the USA and available as Tribenzor....

CHMP continues to monitor safety profile of Pradaxa (Boehringer) for VTE

The EMA has issued a safety update on VTE treatment Pradaxa/Rendix, from Boehringer. It reports that the Agency is aware of recent media interest regarding fatal cases of bleeding in patients treated with the drug, but the CHMP is of the opinion that the recommended changes to the use of Pradaxa adequately manage the risk of bleeding. A worldwide total ...

FDA investigates longitudinal failure of ION Coronary Stent (Boston Scientific)

According to a case report in the Journal of Interventional Cardiology, a patient experienced a heart attack after the recently marketed ION Coronary Stent (called the Taxus platinum in Europe), from Boston Scientific, in his artery shortened and accordioned. The ION Coronary Stent was approved by the FDA earlier this year. According to Cindy Grines, of the Detroit Medical Center ...

Trial comparing Xience V (Abbott) with Endeavor Resolute (Metronic) shows non-inferiority for PCI patients

The TWENTE clinical trial, which compared two second generation drug-eluting stents – the Endeavor Resolute zotarolimus stent from Medtronic and the Xience V everolimus-eluting stent from Abbott – established non-inferiority between the two stents as measured by the primary endpoint: target vessel failure (TVF) at one year. Both stents also demonstrated low rates of stent thrombosis. TVF at one year ...

PolarCath PD System (Boston Scientific) decreases risk of In-stent Restenosis in Diabetic patients

A clinical trial of patients with Diabetes has demonstrated that cryoplasty post-dilitation using the PolarCath Peripheral Dilatation System, from Boston Scientific, compared to conventional balloon angioplasty in the superficial femoral artery (SFA) decreased the risk of In-Stent Restenosis (ISR). Diabetes is associated with increased risk of in-stent restenosis after SFA stenting with nitinol self-expanding stents (nSES). The objective of the ...

Trial of Cre8 polymer-free stent (CID) shows promising results for patients with Coronary Artery Lesions

Researchers have found that the Cre8 polymer-free amphilimus-eluting stents, from Carbostent and Implantable Devices(CID), in de novo coronary artery lesions showed a significantly lower in-stent late loss at six months compared to paclitaxel-eluting stents with permanent polymers. NEXT is a prospective, randomized trial comparing Cre8 polymer-free amphilimus-eluting stent to a paclitaxel-eluting stent. A total of 323 patients were enrolled, with ...

Merck terminates early the TRACER study of vorapaxar in Acute Coronary Syndrome

Merck Inc. has announced that the Phase III TRACER study of vorapaxar,a selective PAR-1 Thrombin Receptor Antagonist, was terminated early as the drug did not reduce the primary composite endpoints (CV Death, Myocardial Infarction, Stroke or Recurrent Ischaemia)and increased the risk of major bleeding, including intracranial haemorrhage. The secondary prevention trial called TRA-2P with vorapaxar in patients who had already ...

Combo Dual Therapy Stent (Orbus Neich) safe and effective in Heart Disease trial

A randomized comparison of the Combo Dual Therapy Stent, from Orbus Neich, which combines low-dose sirolimus delivery from an abluminal biodegradable polymer matrix with a covalently bound anti-CD34 antibody layer, with a paclitaxel-eluting stent, showed that the dual therapy stent effectively controls neointimal proliferation and was shown to be safe and effective. The REMEDEE trial was designed to demonstrate the ...

Xarelto(Bayer/Johnson &Johnson) success in ATLAS ACS 2 TIMI 51 study in Acute Coronary Syndrome

Xarelto (rivaroxaban) from Bayer/Johnson & Johnson twice daily with standard anti- platelet therapy significantly reduced both the rate of cardiovascular death, myocardial infarction and stroke in Acute Coronary Syndrome patients compared to those receiving standard anti-platelet therapy alone. In addition Xarelto 2.5 mg in combination with standard therapy significantly reduced mortality. Results from the ATLAS ACS 2-TIMI 51 study were ...

ABSORB trial Five year and Two year results for the Bioresorbable Vascular Scaffold(Abbott Vascular)

Positive long-term data are reported from the two-stage ABSORB trial, which is evaluating the ABSORB drug eluting bioresorbable vascular scaffold (BVS) from Abbott Vascular for the treatment of coronary artery disease. Five-year results from the first stage and two-year and 18-month data from the second stage of the ABSORB trial were recently presented at the 2011 American Heart Association's Scientific ...

Eliquis versus enoxaparin in ADOPT study for VTE acutely ill patients

Phase 111 ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial evaluated Eliquis (apixaban) versus enoxaparin in acutely ill medical patients and showed that Eliquis did not meet the primary efficacy outcome of superiority to enoxaparin for the endpoint of venous thromboembolism (VTE) and VTE-related death at day 30. The apixaban arm had a 13 percent lower rate of events ...

Cangrelor (AstraZeneca) maintains platelet inhibition without major bleeding in Acute Coronary Syndrome patients

New data demonstrates that intravenous use of cangrelor, from AstraZeneca, was effective at maintaining platelet inhibition in patients on thienopyridines who required bypass surgery. The data is from BRIDGE, a multicenter trial in 210 patients with Acute Coronary Syndrome (ACS) or treated with a coronary stent on a thienopyridine awaiting coronary artery bypass grafting (CABG) to receive either cangrelor or ...

Thrombosis risk in early drug eluting stents

The risk of late stent thrombosis (ST) in the first generation of drug-eluting stents continues for up to seven years after implantation, and certain types of patients, including smokers and those who are younger, are at higher risk, according to results of the DESERT registry. There is an existing need to understand the factors predicting ST and define those patients ...

ADAPT-DES registry data for ACS patients shows risk of Stent Thrombosis

Data on the ADAPT-DES registry presented at the 23rd annual Transcatheter Cardiovascular Therapeutics scientific symposium shows patients with Acute Coronary Syndrome and/or Diabetes who show poor response to dual antiplatelet therapy as measured by platelet function testing are at greater risk of stent thrombosis after PCI with drug-eluting stents. The researchers found that absolute and relative levels of platelet inhibition ...

FDA approves Ovation Abdominal Stent Graft System (Trivascular) for Abdominal Aortic Aneurysm patients

The FDA has approved the Ovation Abdominal Stent Graft System, from Trivascular, which provides patients with small arteries the option of less invasive surgery to repair their potentially life-threatening Abdominal Aortic Aneurysms. Such aneurysms can be repaired through open surgery or less invasively using a stent graft. However this treatment depends on the patient’s anatomy. A small number of people ...

Xarelto(Bayer/Johnson & Johnson) is FDA approved for Stroke prevention in patients with non valvular atrial fibrillation

The FDA has approved Xarelto (rivaroxaban) from Bayer HealthCare/Johnson & Johnson for prevention of stroke in patients with nonvalvular atrial fibrillation, making it the first oral direct factor Xa inhibitor to secure an indication for stroke prevention.The drug had already been approved for prevention of deep vein thrombosis in patients undergoing joint replacement surgery...

NICE recommends Pradaxa for Stroke Prevention in non vavular atrial fibrillation patients

NICE has made a final appraisal determination that recommends the direct thrombin inhibitor Pradaxa (dabigatran etexilate) from Boehringer as an option for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation with one or more of the following risk factors •previous stroke, transient ischaemic attack or systemic embolism; •left ventricular ejection fraction below 40%; •symptomatic heart failure of ...

Lixiana development in VTE for USA and EU is discontinued

The US and EU development of Lixiana (edoxaban) from Daichi Sankyo is discontinued for the prevention of venous thromboembolic events after orthopaedic surgery although the drug is approved in Japan for that indication. Daiichi Sankyo will concentrate on the indication of stroke prevention in atrial fibrillation, for which results from the ongoing ENGAGE AF-TIMI 48 Phase III trial which compares ...

FDA approves Xience Prime Everolimus Coronary Stent

The FDA has given approval for the next-generation Xience Prime Everolimus Eluting Coronary Stent System (Xience Prime),from Abbott Vascular, for the treatment of coronary artery disease. The decision was supported by the clinical results from the SPIRIT group of trials. Xience Prime uses the same drug and biocompatible polymer as the Xience V Everolimus Eluting Coronary Stent System and features ...

Lipitor ineffective for Atherosclerosis in pediatric Lupus

A trial to determine the efficacy and safety of Lipitor (atorvastatin), from Pfizer, in preventing subclinical Atherosclerosis progression in pediatric-onset Systemic Lupus Erythematosus (SLE) found that the therapy was ineffective in reducing Atherosclerosis progression in children and adolescents. However results from the trial showed that the treatment could benefit patients with more severe SLE who were not included in the ...

NICE final guidance recommends Briique in Acute Coronary Syndrome

Brilique (ticagelor) from AstraZeneca has a positive recommendation from NICE, the health technology appraisal body for England and Wales in its final guidance. NICE recommends Brilique in combination with aspirin, for up to 12 months in patients with ST-segment-elevation myocardial infarction (STEMI) that is to be treated with primary percutaneous coronary intervention or non-ST-segment-elevation myocardial infarction (NSTEMI). It is also ...

Genetics and Plavix/Iscover play role in risk of post-stent thrombosis

A new study published in JAMA shows that it is possible to identify genetic or other factors in patients who have received a coronary stent which give this sub-population a higher potential risk of experiencing a blood clot within the stent. Despite the use of dual antiplatelet therapy - DAPT; aspirin and Plavix/Iscover (clopidogrel), from BMS and Sanofi-Aventis - which ...

AstraZeneca to present positive health economics data on Brilique/Brilinta at ISPOR meeting in November

AstraZeneca will present key results from health economics sub-studies from the PLATO trial at the upcoming International Society for Pharmacoeconomics and Outcomes Research (ISPOR) EU meeting, 5-8 November in Madrid. Data from eight countries will show that using Brilique/Brilinta plus aspirin to treat acute coronary syndrome patients for one year is associated with cost-savings, gain in quality-adjusted life years, and ...

Brilinta/Brilique is reviewed for ACS by IQWiG the German Health Quality Institute

Brilique/Brilinta (ticagrelor) from AstraZeneca has been reviewed by the German Institute for Quality and Efficiency in Health Care (IQWiG) ) for its use in Acute Coronary Syndrome (ACS) in comparison with conventional therapies. The Institute has come to the conclusion that ticagrelor provides considerable added benefit to patients with "mild" myocardial infarction without the typical changes in the ECG (NSTEMI), ...

Trial of Omega Platinum Chromium Coronary Stent System now enrolling patients

Boston Scientific has started enrollment in the OMEGA clinical trial to evaluate the safety and effectiveness of its Omega Platinum Chromium Bare-Metal Coronary Stent System in treating patients with a single coronary artery lesion. The trial will enroll 328 patients at 40 sites in the U.S. and Europe. Rates of target lesion failure (TLF), a composite measure that includes target ...

Xience Prime/Xience V stents as alternative to CAGB in EXCEL trial

Abbott Vascular announces the enrollment of the first patients in the EXCEL study which will assess the safety and effectiveness of the Xience Prime/Xience V everolimus eluting coronary stent as an alterantie to coronary artery by pass grafting (CABG) in patients with Left Main Disease, a high risk sub set of Coronary Artery Disease.Joseph Sabik, M.D., chairman, Department of Thoracic ...

Astellas cancels its oral Factor Xa inhibitor ,darexaban

Astellas Pharma has decided to cancel its oral Factor Xa inhibitor, darexaban, after considering the competitive market for anticoagulants and the difficulty in finding a partner for the drug....

Xarelto shows benefit for ACS patients

Xarelto (rivaroxaban) from Bayer HealthCare, cuts the rate of heart attacks, strokes, myocardial infarction, and cardiovascular death compared to placebo, according to data from a Phase III study involving patients with Acute Coronary Syndrome (ACS). However, according to this study, patients who took Xarelto also face a higher risk of major bleeding not linked to coronary artery bypass graft surgery. ...

Carillon Mitral Contour System receives CE mark for Cardiac Surgery

The EU has awarded the CE mark for the newly enhanced version of the Carillon Mitral Contour System, a novel therapy fom Cardiac Dimensions, for treating heart failure patients suffering from functional mitral regurgitation (FMR). The Carillon Mitral Contour System combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and ...

CHMP recommends Edarbi/Ipreziv for Hypertension

The CHMP recommends Edarbi/Ipreziv (azilsartan medoxomil)from Takeda for essential hypertension.Azilsartan medoxomil blocks the angiotensin II type 1 receptors and inhibits the renin angiotensin aldosterone system, reducing blood pressure. The drug was approved by the FDA in February 2011.Takeda sees the drug as the successor to candesartan whose patent will expire in 2012....

Xarelto reccommended in Europe for DVT, Stroke and AF

Bayer HealthCare’s oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for both the prevention of Stroke and systemic embolism in adults with non-valvular Atrial Fibrillation (AF), as well as for the treatment of Deep Vein Thrombosis (DVT) and prevention of recurrent DVT and Pulmonary Embolism (PE) following an ...

CHMP recommends Onduarp for Hypertension

The CHMP recommends Onduarp (telmisartan plus amlodipine) from Boehringer for Essential Hypertension. The combination is FDA approved as Twynsta. The combination will be directed at difficult to treat BP patients and those having Type 2 Diabetes or who are obese or elderly....

Imatinib effective in Pulmonary Arterial Hypertension

The pivatol Phase III IMPRES clinical trial showed that the investigational therapy QTI571 (imatinib), known as Gleevec and Glivec in oncology indications from Novartis, significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH) after 24 weeks compared with placebo. Evidence indicates that QTI571 targets an underlying cause of PAH by counteracting uncontrolled growth of arterial smooth muscle cells. ...

Eliquis launched in UK for VTE

BMS and Pfizer have launched their oral direct Factor Xa inhibitor, Eliquis (apixaban), in the UK for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or knee replacement surgery....

CHMP recommends triple combination Rasitrio for Hypertension

The CHMP has adopted a positive opinion for Rasitrio (aliskiren/amlodipine/HCTZ )from Novartis for the treatment of high blood pressure.Rasitrio has been recommended as replacement therapy in patients whose blood pressure is adequately controlled on a combination of its components given concurrently at the same dose level as in the combination.Adherence to treatment is often very challenging for patients requiring three ...

EMA confirms risk benefit of Multaq

EMA has confirmed a positive benefit-risk balance for Multaq (dronedarone) from Sanofi- Aventis for the treatment of a newly defined population of paroxysmal and persistent Atrial Fibrillation patients, following its review under the Article 20 procedure. A new indication for Multaq is: indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or ...

New Drug Eluting Stents safer for PCI patients

Results from the SCAAR Study, presented at the European Society of Cardiology Congress 2011, showed that Percutaneous Coronary Intervention with "new generation" Drug Eluting Stents (DES), was associated with a 38% lower risk of clinically meaningful restenosis and a 50% lower risk of stent thrombosis compared to old generation DES. The SCAAR study evaluated the long-term outcome in all patients ...

EMA confirms risk benefit of Multaq

EMA has confirmed a positive benefit-risk balance for Multaq (dronedarone) from Sanofi- Aventis for the treatment of a newly defined population of paroxysmal and persistent Atrial Fibrillation patients, following its review under the Article 20 procedure. A new indication for Multaq is: indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or ...

New review of Cryoballoon Ablation treatment for Atrial Fibrillation

A new research review comparing the efficacy and safety of cryoballoon ablation for Atrial Fibrillation finds that a single cryoballoon ablation procedure for paroxysmal AF results in high acute and medium-term efficacy rates, with lower success rates when used as stand-alone therapy for persistent AF. The rate of complications is relatively low and includes a 6.38% incidence of PNP, most ...

Absorb bioresorbable vascular scaffold in Critical Limb Ischaemia

Abbott initiates ABSORB BTK, an international clinical trial evaluating the safety and efficacy of the Absorb bioresorbable vascular scaffold for the treatment of below-the-knee critical limb ischemia. Critical limb ischemia, a severe form of peripheral artery disease occurs when blocked vessels impair blood flow to the lower extremities, which can eventually lead to limb amputation. Absorb restores blood flow by ...

FDA warns Multaq increases risk of death, stroke and heart failure in patients with Permanent Atrial Fibrillation

According to the FDA, analysis of preliminary clinical trial data reveals that patients with permanent Atrial Fibrillation who take antiarrhythmic medication Multaq (dronedarone), from Sanofi-Aventis, have double the risk of death and double the risk of being hospitalised for heart failure or developing stroke compared to those on a placebo. This study of the drug's benefits for patients aged 65+ ...

Merck Inc. returns rights to betrixaban to Portola Pharma

Merck will return to Portola Pharma all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation (SPAF). This decision was made following a review of Merck's investigational portfolio....

MiStent (Micell Technologies) enters Phase III trial for CAD

Micell Technologies,Inc. announced it has enrolled the first patient in the DESSOLVE II (DES with Sirolimus and a bioabsorbable pOLymer for the treatment of patients with de noVo lesions in the native coronary arteries) clinical trial. This clinical investigation is being conducted to support CE Mark approval of the company's MiStent Drug-Eluting Coronary Stent System and compares the MiCell MiStent ...