Article preview from Medtech Insight - March 27, 2013
The PREVAIL study of Boston Scientific’s Watchman left atrial appendage (LAA) closure device was primarily positive, but will it be enough to win FDA approval for the device?
Article preview from Medtech Insight - March 27, 2013
Boston Scientific Corp. believes the results from the PREVAIL trial are enough to finally secure US Food and Drug Administration approval for the firm’s Watchman left atrial appendage (LAA) closure device to prevent stroke in patients with atrial fibrillation (AF), but skepticism about the device lingers among some cardiologists.
The company released preliminary results from PREVAIL, which compared Watchman with long-term warfarin therapy in patients with nonvalvular AF, in conjunction with the 2013 American College of Cardiology (ACC) Scientific Sessions, held in San Francisco earlier this month.
The data were scheduled to be reported by David Holmes, MD, of the Department of Cardiovascular Diseases at the Mayo Clinic as part of the late-breaking clinical trial presentations on March 9, but Boston Scientific announced the trial outcomes in advance of ACC’s embargo, causing the meeting organizers to take the highly unusual step of pulling the trial from the program. Holmes made the announcement to a packed hall just prior to the scheduled presentation time. Thus, the data did not get the same type of formal public vetting it would have as an official late-breaking presentation, although ironically, the circumstances surrounding the trial perhaps attracted even more attention to the data than would have been the case had it actually been presented.
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