Dr. Richard L. Page
The panel chair, Dr. Richard L. Page, chair of the department of medicine at the University of Wisconsin, Madison, said he would have voted positively on the risk-benefit question but would also change the indication, which as written, reflects the patients that were studied. “I have heard consensus from everyone in the room, including the sponsor, that this is not first-line [therapy]. ... We just need the FDA and sponsor to work together to develop a description ... or indication that’s appropriate and gives this important technology a place in our armamentarium to care for our patients with atrial fibrillation.”
The FDA usually follows the recommendations of its advisory panels. The panel members had no potential conflicts to disclose. If approved, the Watchman device would be the first device available that is an alternative to medical therapy for the prevention of stroke in patients with AF.