After much debate, the U.S. Food and Drug Administration (FDA) has finally given the green light to Boston Scientific's Watchman atrial fibrillation (AF or A-fib) heart device.
The medical firm's heart device - dubbed Watchman Left Atrial Appendage Closure (LAAC) Device - is basically a substitute for blood thinners meant to prevent stroke.
Boston Scientific became the owner of the device after its acquisition of Atritech in 2011. However, even though the Watchman LAAC Device has been available for commercial use since 2009 internationally, the FDA needed to review its approval in the U.S. In October 2014, an advisory panel from the FDA voted 6 to 5 in favor of the approval, considering the benefits of the device vis-à-vis the risks.
However, the panel was divided 7 to 6 over its effectiveness when compared to stroke drug Warfarin, deeming it less effective.
"The device is an important step forward in stroke management for patients with AF," noted Vivek Reddy M.D., director of the Cardiac Arrhythmia Service at the Mount Sinai Medical Center. "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 Watchman LAAC Device is shaped like a mini umbrella and operates by closing a user's left atrial appendage (LAA) in a bid to capture the clots. The clots are basically prevented from shifting to the brain. Prevention in turn reduces the risk of getting a stroke, as well as systemic embolism.
The heart device is implanted in an individual with non-valvular AF via a slim catheter on the pouch-like LAA. The LAA accounts for over 90 percent of the blood clots that result in strokes, which arise from the left section of the heart in individuals who suffer from non-valvular AF.
Boston Scientific's Watchman LAAC Device will be a non-drug alternative to Warfarin.
Joe Fitzgerald, Boston Scientific's EVP and president of Rhythm Management, said that the heart device could potentially change the way stroke risk treatment is handled.