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News Breaks
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.
News For BSX From The Last 14 Days
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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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