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News Breaks
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."
News For BSX From The Last 14 Days
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October 20, 2014
08:16 EDTBSXBoston Scientific initiates PLATINUM Diversity trial
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07:20 EDTBSXInternational Continence Society to hold annual meeting
ICS Annual Meeting 2014 is being held in Rio de Janeiro, Brazil on October 20-24.
07:11 EDTBSXAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
October 16, 2014
16:32 EDTBSXBoston Scientific announces pacemaker CE mark with options for MRI
Boston Scientific has received CE Mark approval for the ACCOLADE pacemaker family. When implanted with the company's INGEVITY leads, ACCOLADE pacemakers are the first to enable patients to receive full-body MRI scans in both 1.5 Tesla and 3.0 Tesla systems. In addition, the Boston Scientific ImageReady technology offers the most flexible MRI options, allowing higher energy scan sequences, and featuring a programmable MRI timer designed to improve patient workflow. In addition to the CE mark approval and launch of the ACCOLADE pacemaker family, Boston Scientific received CE Mark approval for the VISIONIST and VALITUDE CRT-Ps with quadripolar pacing technology. When paired with the ACUITY X4 pacing leads, these systems offer many options to reach and pace the target location in the left ventricle, potentially improving the patient response to CRT therapy.
15:10 EDTBSXAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
October 8, 2014
20:03 EDTBSXBoston Scientific confirms FDA panel votes for WATCHMAN device
After reviewing updated data and analysis for the Boston Scientific Corporation WATCHMAN Left Atrial Appendage Closure Device, the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted in favor of the Device. By a vote of 6 to 5, with 1 abstention, the panel concluded that the benefits of the WATCHMAN Device outweigh the potential risks. The panel voted that there is reasonable assurance that the device is safe, with a 12 yes to 0 no vote. On the question of reasonable assurance of effectiveness, the panel vote was unfavorable with a 6 yes to 7 no vote. The panel provided substantial input and guidance related to the proposed Indications for use and target patient population. There was widespread agreement among the panel members that the device provides a much needed alternative to long-term anticoagulation for some patients. While not bound by this vote, the FDA takes Advisory Panel comments and recommendations into account when reviewing the WATCHMAN Device application. The company is committed to working with the FDA to address the panel's comments.
18:42 EDTBSXBoston Scientific Watchman Device receives votes from FDA panel, Dow Jones says
The FDA Panel voted 6 to 5 that benefits of Boston Scientific's Watchman device outweigh the risks, Dow Jones reports. The panel voted 12 to 0 that the Watchman device is safe, and the panel voted 7 to 6 that the Watchman device is not effective, Dow Jones added.
07:24 EDTBSXFDA Circulatory Systems Devices Panel to hold a meeting
The Committee discusses, makes recommendations and votes on information related to the Pre-Market Approval Application regarding Boston Scientificís WATCHMAN Left Atrial Appendage (LAA) Closure Technology in a meeting being held in Gaithersburg, Maryland on October 8 at 8 am. Webcast Link
October 6, 2014
11:13 EDTBSXWells sees 60%-70% chance of positive FDA panel for Boston Scientific
After the FDA posted the briefing documents for the Watchman advisory committee meeting scheduled for October 8, Wells Fargo says it still believes chances of a positive panel and FDA approval are 60%-70%. The firm views the panel's focus on the "totality of data" is a positive signal. It has an Outperform rating on Boston Scientific.

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