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Clinical Laboratory
Phase III results using E 5564 (Eisai) show no significant benefit for Sepsis
21-Mar-2013A 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 ...
CytoFab (BTG/AstraZeneca) fails Sepsis trial
09-Aug-2012BTG 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 ...
Endurant AAA Stent Graft System(Medtronic) two year results
17-Apr-2012Medtronic 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 approves HeliFX Aortic Securement System (Actus Endosystems) for treating aortic endografts
25-Nov-2011The 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. ...
FDA approves Ovation Abdominal Stent Graft System (Trivascular) for Abdominal Aortic Aneurysm patients
05-Nov-2011The 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 ...
Xigris is withdrawn from all markets for Septic Shock
25-Oct-2011Xigris(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 ...
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