|Boston Scientific is one step closer to FDA approval for its Watchman device--courtesy of Boston Scientific|
Boston Scientific ($BSX) is one step closer to getting FDA approval for its Watchman device, completing enrollment in a confirmatory study for the atrial fibrillation-treating tech.
The disorder, an irregular heartbeat, affects about 15 million people worldwide, and the ailment leads to clotting and increased risk of stroke. Boston Sci's implantable device, already available in more than 30 countries, is designed as an alternative to problem-ridden warfarin, capturing clots in the heart to cut back stroke risk.
The current study involves more than 400 patients with atrial fibrillation and will test Watchman against traditional warfarin therapy. Boston Sci says it will conduct the trial and, after following up with patients 6 months after treatment, file with the FDA for approval.
It has been a long road for Watchman since Boston Sci acquired the tech in its 2011 purchase of Atritech. The company has been studying the device ever since, most recently completing a trial that demonstrated Watchman reduced the risk of stroke by 75% over 6 months, and the company is confident it will get FDA approval and launch the tech this year.
Kenneth Stein, the company's CMO, said atrial fibrillation presents a huge global unmet need--and a big potential payday for Boston Sci. But it won't be the only game in town. St. Jude Medical ($STJ) saw a big boost in its irregular heartbeat-treating techs in the first quarter of this year, and more devicemakers are likely to enter the fold on the heels of study data saying cardiac ablation devices are more effective in treating the ailment than drug therapies.
- read the company's release
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