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May 11, 2014
14:50 EDTBSXBoston Scientific's LATITUDE demonstrated reduction in mortality/hospitalization
Patients using the Boston Scientific Corporation LATITUDE Remote Patient Management system with wireless telemetry demonstrated significantly lower mortality and fewer hospitalizations than patients with LATITUDE-compatible devices who were not followed on the system, according to results from the PREDICt-RM study. The results were presented at Heart Rhythm 2014, the Heart Rhythm Society's 35th Annual Scientific Sessions in San Francisco. PREDICt-RM demonstrated a 33% relative reduction in the risk of death in patients with Boston Scientific ICDs and CRT-Ds who were remotely monitored via the LATITUDE wireless remote monitoring system, compared to Boston Scientific ICD and CRT-D patients who were not remotely monitored. Additionally, these patients experienced a 19% relative reduction in hospitalizations for any cause. The study outcomes were presented by Dr. Joseph Akar, associate professor of medicine at Yale University and the Center for Outcomes Research and Evaluation, CORE, in New Haven, CT, and are a result of a research collaboration between Yale CORE, the American College of Cardiology, ACC, and Boston Scientific. "The PREDICt-RM results demonstrate improved outcomes for those ICD and CRT-D patients using the LATITUDE wireless Remote Patient Management system," said Dr. Joseph Akar. "Despite the widespread availability of this technology, we know that it is underutilized. Our hope is that this study may inform clinical practice guidelines and promote the routine use of this technology in daily practice."
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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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August 19, 2014
05:14 EDTBSXBoston Scientific, ASAHI INTECC announce joint development programs
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