WASHINGTON (dpa-AFX) - Medical devices maker Boston Scientific Corp. (BSX) Wednesday said the U.S. Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee voted in favor of the company's WATCHMAN Left Atrial Appendage Closure or LAAC 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. This follows review of updated data and analysis for the device.
Further, the panel voted that there is reasonable assurance that the device is safe. On the question of reasonable assurance of effectiveness, the panel vote was unfavorable with 6 voting for and 7 against.
The panel provided substantial input and guidance related to the proposed indications for use and target patient population.
According to the company, there was widespread agreement among the panel members that the device provides a much needed alternative to long-term anticoagulation for some patients.
The FDA takes advisory panel comments and recommendations into account when reviewing the WATCHMAN device application. The company said it is committed to working with the FDA to address the Panel's comments.
The WATCHMAN device was approved for sale in Europe in 2005 and is currently approved in over 70 countries across the globe. In the U.S., the WATCHMAN device is an investigational device, limited to investigational use and not available for sale.
'Today's recommendation by the Panel is another step toward making this innovative technology available to high risk patients with non-valvular atrial fibrillation who are eligible for warfarin, but who have reasons to seek an alternative to long-term therapy,' said Kenneth Stein, M.D., Chief Medical Officer, Rhythm Management, Boston Scientific.
BSX closed up 3.1 percent on Wednesday at $12.14.
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