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After a long and drawn out approval process spanning over a decade, the FDA has finally given approval to Boston Scientific’s Watchman atrial fibrillation (A-Fib) heart device.

“We’re thrilled we finally got it across the goal line,” Boston Scientific Senior Vice President Kenneth Stein said in an interview. “It’s a complex device for the agency to evaluate, and that’s part of the reason it was more arduous than what we’re used to with other devices.”

The Watchman is being positioned as an alternative to warfarin in order to reduce thromboembolism from the left atrial appendage in patients with non-valvular A-Fib and who are at an increased risk for stroke and systemic embolism.

“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 approval is a victory for Boston Scientific allowing them to offset slow growth in their pacemaker and implanted defibrillators product lines. Boston Scientific estimates the Watchman market to be $500 million annually. However, newer treatment options may limit its overall market potential.

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