“We’ve been very pleased with the real-world clinical outcomes and positive physician feedback for the Watchman FLX device in Europe and are excited to extend availability of this next-generation technology to patients and clinicians throughout the U.S.,” said Joe Fitzgerald, president of Boston Scientific’s interventional cardiology division, in a news release.
It is available in broader size options than the previous-generation device and can treat a wider range of patient anatomies. Watchman FLX’s fully rounded design offers physicians the ability to safely enter, and maneuver within, the left atrial appendage, the company said.
It received the CE Mark in Europe in March 2019. The device has a new frame design that allows for optimal engagement with the tissue for long-term stability and a faster, more complete seal, the company added. It is indicated for people who have atrial fibrillation that is not caused by a heart valve problem.īoston Scientific touted the Watchman FLX as easier to implant, re-capturable and re-positionable.
The Marlborough, Mass.-based company describes the Watchman FLX as a permanent implant designed to close off the left atrial appendage and thus reduce the risk of stroke without the bleeding danger associated with blood-thinners. The FDA has approved the next-generation of Boston Scientific’s (NYSE: BSX) Watchman left atrial appendage closure (LAAC) device, the company announced today.
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