News

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 ...

Phase III study of Sufentanil NanoTab PCA System (AcelRx Pharmaceuticals) shows superiority to morphine for Pain relief

Clinical results from a Phase III trial of Sufentanil NanoTab PCA System, from AcelRx Pharmaceuticals, for the treatment of moderate-to-severe Acute Pain in the hospital setting demonstrate that sufentanil delivered via the NanoTab System has a significantly greater pain intensity reduction in the first four hours after treatment than IV PCA morphine (p<0.01).

In addition, there were fewer patients throughout ...

FDA approves Kcentra (CSL Behring)to reverse vitamin K antagonist anticoagulation with major bleeding

The FDA on 29 April 2013 has approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States. Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions ...

Air Band (Maquet Cardiovascular) given FDA 510(k) and EU CE Mark approval for use in Surgery

The FDA has given 510(k) clearance for the Air Band radial compression device, from Maquet Cardiovascular. The device is indicated to assist hemostasis of the radial artery after a transradial procedure, and is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist during Surgery. Additionally, the EU has given CE ...

OverStitch Endoscopic Suturing System gets CE Mark

Apollo Endosurgery, Inc., a company focused on the development of devices that enable a new generation of endoscopic surgical procedures, announced that its OverStitch Endoscopic Suturing System has received the European Union's CE Mark. The company plans to immediately launch the system to select centers in several European countries.

The company is working with distributors in several European countries ...

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 ...

Phase III results using E 5564 (Eisai) show no significant benefit for Sepsis

A Phase III trial to evaluate the safety and efficacy of E 5564 (eritoran), from Eisai, in reducing mortality in patients with severe Sepsis shows the drug failed to demonstrate a significant effect on reducing all-cause 28-day mortality or 1-year mortality, compared with placebo. The randomized, multinational trial was conducted in 197 intensive care units. Patients were enrolled from June ...

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 ...

FDA approves Lymphoseek (Navidea Biopharma) for intraoperative Lymphatic Mapping

The FDA has approved on 13 March 2013, Lymphoseek (technetium Tc 99m tilmanocept) Injection, from Navidea Biopharmaceuticals , a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with Breast Cancer or Melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Lymphoseek is an imaging drug that helps locate lymph nodes; it is not ...

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 ...

MRI-guided focal laser ablation system (Visualase) shows promise in patients with Prostate Cancer

A small Phase I trial of an MRI-guided focal laser ablation system, from Visualase, designed to treat the diseased portion of the Prostate in patients with Prostate Cancer, suggests the technique is safe and can be performed without the troubling complications associated with more aggressive therapies. This study enrolled nine men with biopsy-confirmed, low-risk Prostate Cancers with an MRI of ...

Paion AG initiates Phase II trial of remimazolam for Anaesthesia

Paion AG will conduct a Phase II trial with short acting anaesthic/sedative remimazolam in general anaesthesia in cardiac surgery in the second half of 2013.Ono Pharma have completed a successful Phase II trial for remimazolam in Japan in general aneasthesia and are conducting a Phase II/III trial.

The clinical studies performed with remimazolam comprise four Phase I and three Phase ...

Positive results in Phase III trial of Sufentanil NanoTab PCA (AcelRx Pharmaceuticals) for patients with Post-Operative Pain

Top-line data results demonstrating that the first of two pivotal placebo-controlled Phase III studies for sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System, from AcelRx Pharmaceuticals, met its primary endpoint. The primary endpoint evaluated Pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery.

Results demonstrated that patients ...

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 ...

FDA approves Sculptor Robotic Guidance Arm (Stanmore Implants) for Surgery

Stanmore Implants has received 510(k) clearance from the FDA to market its Sculptor Robotic Guidance Arm for precision implant placement in unicompartmental knee Surgery, also known as partial knee resurfacing. The Sculptor RGA system is a robotic guide to assist with bone preparation, performed by a high speed cutting burr attached to the robotic arm, which limits the surgeon's operation ...

FDA approves Edge Radiosurgery Suite (Varian Medical Systems) for Radiation Therapy

The FDA has given 510(k) clearance for Varian Medical System's Edge Radiosurgery Suite, a new dedicated system for performing advanced Radiation Therapy using new real-time tumor tracking and motion management technologies. The system includes an integrated six degrees of freedom couch that provides the accuracy, precision, and flexibility needed to position patients. It also allows expanded use of fluoroscopy and ...

EU approves APPY1 test (Venaxis) for patients at low risk for acute Appendicitis

The EU has given CE Mark approval to the APPY1 blood-based Appendicitis test, from Venaxis. The unique test is designed to aid in the identification of patients at low risk for acute Appendicitis, allowing for more conservative patient management. APPY1 is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the ...

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 ...

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. ...

Phase III trial of OMS 103HP (Omeros Corp) shows pain reduction in patients after arthroscopic Surgery

New results from the first pivotal Phase III clinical trial evaluating OMS 103HP, from Omeros Corporation, in patients undergoing arthroscopic partial meniscectomy Surgery shows the drug provides significant reduction in pain. The trial's primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) – a patient-reported measure comprised of questions about knee swelling, clicking, catching ...

Navidea Biopharma files Lymphoseek at EMA for Intraoperative Lymphatic Mapping

Navidea Biopharmaceuticals, Inc. a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, has announced that it has submitted a Marketing Authorization Application for its investigational radiopharmaceutical Lymphoseek (technetium Tc 99m tilmanocept) injection, a novel intraoperative lymphatic mapping agent, to the European Medicines Agency. Lymphoseek is used in intraoperative lymphatic mapping , a surgical oncology procedure used primarily in patients with ...

Phase II study of RiaSTAP (CSL Behring) shows the drug has benefits in Critical Care patients

Clinical study results show that RiaSTAP (fibrinogen concentrate [human]), from CSL Behring, can significantly reduce the need for blood transfusion when given in a Critical Care situation, as an intra-operative, targeted first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. The Phase II prospective study, led by Niels Rahe-Meyer of the Clinic for Anesthesiology and Intensive Care Medicine, at ...

Early trial shows promising results with simvastatin in Wound Healing

An lab-based trial has found that topically applied generic statin simvastatin accelerates Wound Healing in diabetic mice, with important implications if the effect occurs in humans with Diabetes. The investigators treated wounds on mice with an application of either simvastatin in petroleum jelly or petroleum jelly alone. Treatment was repeated on days four, seven, and ten. After two weeks, the ...

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 ...

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 ...

Aquacell Ag (Convatec) surgical cover success reported in JAMA

A new study looking at infections following joint replacement surgery finds a 78 percent decrease in joint infections when Aquacell Ag SURGICAL cover dressing from ConvaTec was used. The study found that the infection rate for total joint replacement patients dropped to 0.4 percent when Aquacell Ag SURGICAL cover dressing was used as compared to 1.8 percent when gauze ...

Legion HK Hinge Knee implant launched by Smith & Nephew in US and Canada

Smith & Nephew the global medical technology business, announced the launch of its Legion HK Hinge Knee implant to surgeons in the US and Canada. As the first hinged knee to be designed using normal knee kinematics, the implant provides a new option for those patients facing difficult primary or revision knee surgery....

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 ...

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 ...

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 ...

FDA approve SurgiClear (Covalon Technologies) for Wound Healing

The FDA has cleared SurgiClear (antimicrobial dressing), from Covalon Technologies, to cover and protect Wound sites and wound closure devices, as well as secure other primary dressings to a patient's skin. SurgiClear is the first clear antimicrobial silicone surgical dressing that combines silver and chlorhexidine to provide broad spectrum antimicrobial activity for 7 days. SurgiClear is the only antimicrobial surgical ...

Phase III trials commence for OMS 103HP for Arthroscopic Surgery

Enrollment is complete in the first of two trials from Omeros Corporation, in patients undergoing arthroscopic partial meniscectomy Surgery. The Phase III clinical program for OMS 103HP is assessing the drug's safety and efficacy in improving postoperative joint function and reducing pain following arthroscopic partial meniscectomy surgery. The program is expected to consist of two randomized, double-blind, vehicle-controlled, multicenter trials. ...

Positive interim results for Embrace Advanced Scar Therapy (Neodyne Biosciences)

An interim analysis demonstrates the efficacy of the Embrace Advanced Scar Therapy System from Neodyne Biosciences, within one of the most challenging scar-prone surgical procedures, an abdominoplasty (tummy tuck). The results of the first 28 patients to complete the six month assessment showed a highly significant difference between the expert blinded assessments of scar appearance for the Embrace treated ...

CytoFab (BTG/AstraZeneca) fails Sepsis trial

BTG disclosed top-line results from a Phase IIb study conducted by AstraZeneca which had compared two doses of CytoFab (polyclonal ovine anti-TNF antibody fragments) with a placebo in patients with severeSepsis and/or Septic Shock. Treatment with CytoFab failed to show any significant improvements versus placebo with regard to either the primary endpoint of ventilator-free days or secondary endpoints such as ...

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, ...

EMA approves Axios Stent system (Xlumena) for GI surgery

The EU has given CE Mark approval to market the Axios Stent and Delivery System, from Xlumena, for biliary tract drainage in GI Surgery. The Axios system gives endoscopists a minimally-invasive tool to create a secure connection between the gallbladder or bile duct and the gastrointestinal tract. The Axios Stent is delivered under endoscopic ultrasound guidance using a specially-designed delivery ...

Positive data from Phase III SUMMIT trial of MACI (Genzyme/Sanofi) for cartilage repair

New results show that MACI (matrix-induced autologous chondrocyte implant), from Genzyme/Sanofi, met its co-primary endpoint in a two-year, randomized, controlled clinical trial compared to microfracture, a surgical procedure designed to stimulate the growth of new cartilage.

The pivotal safety and efficacy Phase III trial (SUMMIT) enrolled 144 patients across seven countries in Europe with symptomatic articular cartilage defects in ...

FDA advisory panel does not recommend metal on metal hip replacement implants

The FDA asked an 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, ...

FDA approves Amplatzer Vascular Plug from St Jude Medical

The FDA has approved the Amplatzer Vascular Plug 4 (AVP 4) from St. Jude Medical for for use in transcatheter embolization procedures (minimally invasive procedures that involve the selective blocking of blood vessels) within the peripheral vasculature. Vascular plugs assist physicians in quickly blocking or rerouting blood flow by occluding (closing) abnormal blood vessels. AVP 4 is the latest addition ...

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 ...

FDA approve Magellan Robotic System (Hansen Medical) for Vascular Surgery

The FDA has given 510(k) approval for the Magellan Robotic System, from Hansen Medical, in US. The Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The System has the potential to provide vascular surgeons and other interventionalists the ability to perform fast ...

FDA accepts BLA for human 4-factor prothrombin complex concentrate (CSL Behring) for acute Bleeding

The FDA has accepted a Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC), from CSL Behring, for the urgent reversal of vitamin K-antagonist therapy (i.e., warfarin) in patients with acute major Bleeding. The submission is based on results from three prospective Phase III clinical trials that evaluated the safety and efficacy of PCC in patients who ...

FDA approves VivaSight (ETView Medical) for use in Lung Surgery

VivaSight, from ETView Medical, received clearance of a 510(k) Pre-Marketing Notification Application with the FDA. The company expects to enter the US market with the VivaSight-DL Airway Management System immediately. VivaSight-DL is a single-use disposable medical device, consisting of a dual lumen airway ventilation tube with an integrated continuous high resolution video airway imaging system permitting airway control and lung ...

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 ...

Positive results in Phase III trial of BST-CarGel (Piramal Healthcare) for Tissue Repair

A pivotal Phase III clinical trial of BST-CarGel, from Piramal Healthcare, reveals that when used for Tissue Repair, the treatment results in more repair cartilage of higher quality at 12 months than microfracture, the current orthopaedic standard of care, with a similar safety profile. The trial also met both primary endpoints by reaching statistical significance over microfracture in the degree ...

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 ...

FDA approves Femtosecond (Abbott Medical Optics) for Corneal Surgery

The FDA has approved use of the iFS Advanced Femtosecond Laser from Abbott Medical Optics, to create bow-shaped or curved arcuate incisions in corneal surgery, including cataract surgery. With this new clearance, the iFS Laser now gives surgeons the ability to make precise, bladeless arcuate incisions during surgery and customize the incision for each individual patient.Factors such as placement, length, ...

Medtronic launches Powerease System for Spine Surgery

Medtronic, has announced launched the Powerease System, an innovative system of electronic instruments designed specifically for use in instrumented or reconstructive spine surgery. This system brings new capability to the operating room through compatibility with two of the leading pedicle screw platforms on the market, the CD Horizon Solera Spinal System and the TSRH 3Dx Spinal System, and is integrated ...

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 ...

CE Mark approval for Advantio/Ingenio pacemakers from Boston Scientific for Bradycardia

CE Mark approval has been given and European market launch is taking place for Ingenio and Advantio pacemakers and Invive cardiac resynchronization therapy pacemakers (CRT-P) from Boston Scientific. Pacemakers are designed to treat bradycardia, a condition in which the heart beats too slowly -- usually less than 60 beats per minute -- depriving the body of sufficient oxygen. The Ingenio ...

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 ...

RenalGuard (PLC Medical Systems) trial in Contrast Induced Nephropathy

Results from a new clinical trial of RenalGuard from PLC Medical Systems conducted in Italy -- the first to follow longer-term outcomes -- were presented at the annual conference of the American College of Cardiology (ACC.12), March 24 - 27, 2012, Chicago, Illinois. These results showed that RenalGuard is superior to two alternative methods at reducing rates of mortality, in-hospital ...

Kiva VCF Treatment System (Benvenue Medical/Zimmer) enters KAST trial

Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair announced that over 250 patients have been enrolled in the landmark KAST (Kiva System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial) clinical trial. KAST is evaluating Benvenue Medical's Kiva VCF Treatment System in the largest randomized study to date versus the current standard of ...

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 ...

OncoGenex/Teva initiate Phase III trial for custirsen for Prostate Cancer

OncoGeneX and Teva plan to initiate a new Phase III study to evaluate the ability of custirsen (OGX-011) to improve survival for patients with Prostate Cancer when combined with recently approved, second-line chemotherapy, Jevtana (cabazitaxel). The new study will be conducted in lieu of the Prostate Cancer Saturn Study, which aimed to assess durable pain palliation as a primary endpoint. ...

FDA approves Single-Site Instrumentation for Da Vinci Si Surgical System (Intuitive Surgical)

The FDA has given marketing approval for the Single-Site Instrumentation for the Da Vinci Si Surgical System, from Intuitive Surgical, for laparoscopic Cholecystectomy procedures, the surgical removal of the gall bladder. The da Vinci Surgical System is a surgical platform designed to enable complex surgery using a minimally invasive approach. It is commonly used for prostatectomies, and increasingly for cardiac ...

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 ...

Exparel is FDA approved for Post Surgical Analgesia

Exparel(bupivacaine extended-release liposome injection),a non-opioid local analgesic, is FDA approved for post-surgical analgesia. Exparel provides analgesia for several days with a single intraoperative infiltration. The approval is based on a trial that showed a larger percentage of patients treated with Exparel avoided opioid rescue medication during the first 24 hours after surgery compared to placebo,,7% versus 1%. Exparel combines bupivacaine ...

Xigris is withdrawn from all markets for Septic Shock

Xigris(drotrecogin alfa (activated)) from Eli Lilly ,which was first approved in the USA in 2001 and in the EU in 2002, is now withdrawn in all markets following results of the PROWESS-SHOCK study, which showed the drug did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. While there were ...

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 ...