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April 2, 2014
05:23 EDTBSXBoston Scientific reports favorable results in MADIT-CRT study
Boston Scientific reported favorable results in studies related to cardiac resynchronization therapy, or CRT, platinum chromium stent platforms and transcatheter aortic valve replacement, or TAVR. Boston Scientific announced significant findings from the continued analysis of the landmark MADIT-CRT study, demonstrating a significant and sustained survival benefit in the indicated population. The long-term results demonstrated a 41% relative reduction in the risk of death in patients who received a Boston Scientific defibrillator with CRT compared to patients who received a defibrillator alone. In addition to the mortality benefit, the results demonstrate that these patients experienced a 62% relative reduction in the risk of experiencing a first heart failure event when compared to patients who didn't receive CRT therapy. Boston Scientific released new data that continue to reinforce the advantages of platinum chromium stents. The trial compared the safety and effectiveness of the Boston Scientific Platinum Chromium Everolimus-Eluting Stent System, or PtCr EES, to the Abbott Laboratories Cobalt Chromium Everolimus-Eluting Stent System, or CoCr EES. The results show low event rates out to four years with PtCr EES confirming excellent long-term performance. At four years, the PtCr EES also continued to demonstrate advantages over the CoCr EES. The Boston Scientific Lotus Valve System advanced TAVR technology continued to demonstrate impressive performance at three months.
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September 2, 2014
08:07 EDTBSXBoston Scientific closed agreement to acquire Interventional business of Bayer
Boston Scientific (BSX) closed on its previously announced agreement to purchase the Interventional business of Bayer (BAYRY). The addition of the Bayer Interventional strong commercial organization and innovative technologies supports the Boston Scientific strategy to provide a comprehensive portfolio of solutions to treat peripheral vascular disease. The transaction includes the leading AngioJet Thrombectomy System and the Fetch 2 Aspiration Catheter, which are used in endovascular procedures to remove blood clots from blocked arteries and veins, and the JetStream Atherectomy System, used in an innovative and fast-growing therapy to remove plaque and thrombi from diseased arteries.
August 31, 2014
14:18 EDTBSXBoston Scientific NECTAR-HF trial did not meet primary efficacy endpoint
Boston Scientific has released the primary endpoint results from its NEural Cardiac TherApy foR Heart Failure, NECTAR-HF, clinical trial, the first and only randomized sham-controlled clinical trial investigating vagus nerve stimulation, VNS, for the treatment of heart failure patients. Faiez Zannad, M.D., Ph.D., Professor of Therapeutics and Cardiology and Director of the Clinical Investigation Center at the Institut National de la Sante et de la Recherche Medicale presented the results at the 2014 European Society of Cardiology Congress in Barcelona, Spain. The results will also be published in the European Heart Journal. The study evaluated 96 New York Heart Association,NYHA, Class II-III patients with heart failure and an ejection fraction of less than 35%. All patients continued receiving optimal medical treatment for heart failure, but were randomized 2:1 to treatment or sham, respectively. The trial did not meet the pre-specified six month primary efficacy endpoint of a reduction in left ventricular end systolic diameter as assessed by a blinded echocardiography core laboratory. Quality of life metrics demonstrated significant symptomatic improvement despite the lack of a significant effect on primary and secondary endpoint measures of cardiac remodeling and functional capacity in HF patients. "The careful design and execution of NECTAR-HF has resulted in high quality data that will improve the understanding of the role of VNS in the treatment of patients with heart failure," said Prof. Zannad, NECTAR-HF Principal Investigator. "Although patients receiving therapy reported feeling better as assessed by quality of life questionnaires, the application of VNS failed to reveal clear benefit when compared to sham, because the effect of therapy was no better than sham on echocardiography derived measurements. Inclusion of an appropriate control group is crucial, and a randomized study like NECTAR-HF should be the benchmark for future studies of novel device therapies for the treatment of heart failure." After six months of randomization, control patients begin to receive active therapy. All patients are followed through 18 months for the safety endpoint.
August 29, 2014
17:06 EDTBSXBoston Scientific reports results from multinational stent study
A Boston Scientific prospective, multinational study on stent removability and preliminary long term stricture resolution of benign biliary strictures has been published in the August issue of the peer-reviewed journal, Gastroenterology. The multinational study is being conducted in 11 countries and five continents, and examines removal of fully covered self-expanding metal stents after extended indwell. The 187-patient study was designed to evaluate the ability to remove the Fully Covered WallFlex Biliary RX Stent after extended indwell and to determine treatment success of biliary obstructions resulting from benign biliary strictures. Data highlights: The WallFlex Biliary RX Stents were successfully removed by endoscopy from all 155 patients in whom this procedure was attempted. Stricture resolution without the need to restent at the time of stent removal was successful in approximately 75% of patients. Approximately 85% of these patients remained stricture-free after a mean follow-up of 20 months. The study results demonstrate that FCSEMS are an effective treatment alternative to plastic stents, and may significantly reduce the need for multiple sequential Endoscopic Retrograde Cholangiopancreatogram stent exchanges and the associated complications and costs.
August 28, 2014
17:42 EDTBSXJ&J begins sales process for its medical device unit Cordis, WSJ says
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August 25, 2014
11:09 EDTBSXFDA confirms third Watchman panel for Boston Scientific, says Wells Fargo
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