FDA Panel Gives Mixed Reaction to Boston Scientific's Watchman LAAC Device

October 8, 2014—The Circulatory System Devices Panel of the US Food and Drug Administration (FDA) met in Gaithersburg, Maryland, to consider new data related to the premarket approval application for the first-of-its-kind transcatheter Watchman left atrial appendage closure (LAAC) device (Boston Scientific Corporation), which is indicated to prevent thromboembolism from the left atrial appendage.

The panel was chaired by Richard L. Page, MD, of the University of Wisconsin School of Medicine in Madison, Wisconsin. 

The 12-member voting panel agreed unanimously “Yes” on the first question of whether there is reasonable assurance that Watchman LAAC therapy is safe for use in patients who meet the criteria specified in the proposed indication.

On the second question, whether there is reasonable assurance that the Watchman LAAC therapy is effective for use in for patients who meet the criteria specified in the proposed indication, the panel was split with six “Yes” to six “No” votes, with Panel Chair Dr. Page breaking the tie with a “No” vote.

Finally, on the third question of whether the benefits of the Watchman LAAC therapy for use in patients who meet the criteria specified in the proposed indication outweigh the risks for use in patients who meet the criteria specified in the proposed indication, there were six “Yes” votes, five “No” votes, and one panelist who abstained from voting. 

The FDA’s complete meeting materials, including the FDA’s executive summary, the scheduled agenda, and the full roster of panelists and representatives, are available online. Further background is available in a previous Cardiac Interventions Today news story, which was issued before this meeting.

In a statement from Boston Scientific, the company advised that although the FDA is not bound by this vote, the agency takes advisory panel comments and recommendations into account when reviewing the Watchman device application. The company stated that it is committed to working with the FDA to address the panel’s comments.  

Boston Scientific noted that the panel provided substantial input and guidance related to the proposed indications for use and target patient population. The company added that there was widespread agreement among the panel members that the device provides a much-needed alternative to long-term anticoagulation for some patients.

The committee’s vote followed a review of the most recent clinical data and analysis from two randomized control trials, PROTECT AF and PREVAIL, as well as from the CAP (Continued Access Protocol) and CAP2 registries.

In Boston Scientific’s press release, Vivek Reddy, MD, coprincipal investigator of the PROTECT AF and PREVAIL studies, commented, “There is a strong clinical need for a proven device alternative to long-term warfarin therapy for my high stroke risk patients with nonvalvular atrial fibrillation. I'm encouraged that the panel recognized the importance of having the Watchman device as an option for appropriate patients.” Dr. Reddy is Director of the Cardiac Arrhythmia Service at Mount Sinai Medical Center in New York, New York.

Kenneth Stein, MD, Chief Medical Officer, Rhythm Management, at Boston Scientific, stated, “Today's recommendation by the panel is another step toward making this innovative technology available to high risk patients with nonvalvular atrial fibrillation who are eligible for warfarin, but who have reasons to seek an alternative to long-term therapy. We continue to believe that the totality of the data for the Watchman device provides reasonable assurance of its safety and efficacy as a treatment alternative for these patients. We look forward to our ongoing discussions with FDA.”

The Watchman device was approved for sale in Europe in 2005. It is currently approved in more than 70 countries, with more than 9,000 implantations performed worldwide. Additionally, the Watchman has long-term clinical data from more than 2,400 patients and approximately 6,000 patient-years of follow-up in clinical studies. The device was developed by Atritech, which Boston Scientific acquired in March 2011. In the United States, the Watcman is an investigational device, limited to investigational use and not available for sale, advised Boston Scientific.