Boston Scientific's Watchman Gets FDA Panel Nod

By Jof Enriquez,
Follow me on Twitter @jofenriq

After a tight vote, a Food and Drug Administration (FDA) panel agreed that the benefits outweigh the risks posed by Boston Scientific’s Watchman heart device designed to prevent strokes due to a common arrhythmia. The decision will likely pave the way for market approval next year.

Voting six-to-five with one abstention, members of the FDA Advisory Committee Panel deemed the Boston Scientific product safe, but not particularly effective, for lowering the risk of stroke for patients suffering from atrial fibrillation, the Wall Street Journal reported. The 12-person panel split its decision over the device’s effectiveness, and it required a tiebreaking vote from the chairman to determine that the device is not as effective as warfarin therapy. The panel voted unanimously that the heart implant is safe.

Members of the panel had called the meeting to assess new data from two clinical trials that showed that patients implanted with “the Watchman device had higher rates of stroke caused by blood clots or other debris — the type that accounts for 85% of all strokes — than patients receiving warfarin, a commonly used blood thinner,” according to the WSJ.

Boston Scientific and clinical investigators argued that the device needs to be approved as second-line therapy to patients who are at risk for hemorrhagic strokes and who are poor candidates to receive standard, first-line anticoagulant therapy.

"There is a strong clinical need for a proven device alternative to long-term warfarin therapy for my high stroke risk patients with non-valvular atrial fibrillation," Dr. Vivek Reddy, Director of the Cardiac Arrhythmia Service at Mount Sinai Medical Center and co-principal investigator of the PROTECT AF and PREVAIL studies, said in a statement. "I'm encouraged that the Panel recognized the importance of having the WATCHMAN Device as an option for appropriate patients."

The FDA typically follows the recommendations of its advisory panels, but it is not bound to do so. The agency in 2009 ignored a panel’s recommendation to approve the Watchman device because of questions surrounding the conduct of trials. A second panel in 2013 voted 13-to-one to recommend approval, but the FDA called the third panel which convened this week in light of new data from its manufacturer, the WSJ said.

“It was almost unprecedented to have three panels,” Dr. Rob Schwartz, co-inventor of the device, told the Star Tribune. “I don’t know of anyone who has heard of three panels before. But they wanted to be very clear, because the device was an unusual device and they wanted longer-term follow-up.

The Watchman device is a catheter-inserted heart implant designed to plug the left atrial appendage, a pouch at the left wall of the atrium of the heart with a high predilection for the formation of clots in patients with atrial fibrillation, which affects some 3 million Americans. 

According to the WSJ, Wells Fargo estimates global sales of the Watchman device, which is already approved in Europe, to reach $41 million this year, and up to $170 million in 2018 if it receives FDA approval next year.