Boston Scientific Receives FDA Approval for Watchman Left Atrial Appendage Closure Device

First-Of-Its-Kind Alternative to Long-Term Warfarin Therapy for Stroke Risk Reduction in Patients with Non-Valvular Atrial Fibrillation

Mar 13, 2015

MARLBOROUGH, Mass., March 13, 2015 /PRNewswire/ -- Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN Left Atrial Appendage Closure Device. The Watchman Device offers a new stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. The Watchman Device will be made available to U.S. centers involved in our clinical studies and additional, specialized centers as physicians are trained on the implant procedure.

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The Watchman Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS₂ or CHA₂DS₂-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

"The Watchman Device is an important step forward in stroke management for patients with AF," said Vivek Reddy, M.D., Director of the Cardiac Arrhythmia Service at the Mount Sinai Medical Center and co-principal investigator of the PROTECT AF and PREVAIL studies. "We know that up to 40 percent of patients who are eligible for oral anticoagulation do not take it for numerous reasons¹, highlighting the need for additional treatment options. The Watchman Device is a breakthrough treatment providing those patients who are suitable for warfarin with an implant-based alternative to long-term warfarin therapy while still reducing the risk of stroke."  

The FDA approval of the Watchman Device is based on the robust Watchman clinical program which consists of numerous studies, with more than 2,400 patients and nearly 6,000 patient-years of follow-up. The Watchman clinical program provided strong evidence that the Watchman Device can be implanted safely² and reduces the risk of stroke in eligible patients while enabling most patients to discontinue warfarin³. Additionally, a meta-analysis of all of the randomized trial data demonstrated that while ischemic stroke reduction favored warfarin, the Watchman Device provided patients with a comparable protection against all-cause stroke and statistically superior reductions in hemorrhagic stroke, disabling stroke, and cardiovascular death compared to warfarin over long-term follow-up.⁴

The Watchman Device has been commercially available internationally since 2009 and is the leading device in percutaneous left atrial appendage closure globally.  It is registered in 75 countries and more than 10,000 patients have been treated with the Watchman Device.

Investor Event and Webcast Information
Boston Scientific, in connection with its attendance at the 2015 American College of Cardiology 64th Annual Scientific Session in San Diego, CA, will host an investor event and live webcast to discuss the Watchman Device on Sunday, March 15.  The event, which will include a question and answer session, is scheduled to begin at 1:00 p.m. PT and adjourn at approximately 2:30 p.m. PT and will be hosted by Joe Fitzgerald, executive vice president and president, Rhythm Management, and Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management. Vivek Reddy, M.D., Director of the Cardiac Arrhythmia Service at the Mount Sinai Medical Center will also present. 

A live webcast of the event will be available via the Boston Scientific website. Webcast registration is available on the Investor Relations section of the website at www.bostonscientific.com/investors. Registration at least 15 minutes prior to the scheduled start time is encouraged to ensure a timely connection.

A replay of the webcast will be archived and accessible at www.bostonscientific.com/investors approximately one hour following the completion of the conference call.

About Atrial Fibrillation and Stroke
Non-valvular atrial fibrillation (AF) is an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications.  AF is the most common cardiac arrhythmia, currently affecting more than five million Americans.⁵ Patients with AF have a five-fold increased risk of stroke due to blood stagnating from the improperly beating atrium and the resulting blood clot formation.⁶ Twenty percent of all strokes occur in patients with AF.⁷ Stroke is more severe for patients with AF, as they have a 70 percent chance of death or permanent disability.⁸

The most common treatment for stroke risk reduction in patients with AF is blood-thinning warfarin therapy.  Despite its proven efficacy, long-term warfarin therapy is not well-tolerated by some patients due to numerous quality-of-life tradeoffs - like dietary restrictions and regular blood monitoring - and carries a significant risk for bleeding complications. 

About the Watchman LAAC Device
The Watchman LAAC Device is a catheter-delivered heart implant designed to close the left atrial appendage (LAA) in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF.  The LAA is a thin, sack-like appendix arising from the heart and is believed to be the source of >90 percent of stroke-causing clots that come from the left atrium in patients with non-valvular AF.⁴ Images of the Watchman Device are available at https://bostonscientific.mediaroom.com/image-gallery?mode=gallery&cat=1760.

For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

¹ NCDR Pinnacle Registry
² PROTECT AF, CAP, PREVAIL and CAP2
³ PROTECT AF, CAP, PREVAIL
⁴ POOLED PROTECT AF and PREVAIL data
⁵ Colilla et al., Am J Cardiol. 2013; 112:1142-1147
⁶ Holmes DR, Seminars in Neurology 2010; 30:528–536
⁷ Hart RG, Halperin JL., Ann Intern Med. 1999; 131:688–695 
⁸ Blackshear J. and Odell J., Annals of Thoracic Surgery. 1996; 61:755-759