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LAA Closure Devices: Reaching Critical Mass?

Transcatheter LAA closure devices are starting to amass the level of data required to demonstrate their safety and effectiveness, and, if all goes well, the long-awaited FDA approval of the first such device – Boston Scientific’s Watchman – could finally occur sometme next year. Although LAA closure devices have already taken off in some European countries, US physicians continue to struggle with lingering uncertainties, about the learning curve, procedural safety and how LAA closure will stack up against newer anticoagulant drugs. Regardless of how these issues are eventually resolved, industry leaders see a big opportunity for a successful device in the LAA closure space, with market estimates of $1 billion considered conservative by some.

Whether they turn out to be revolutionary advances or something far less relevant, the promising devices now in development to block off the opening to the heart’s left atrial appendage (LAA; a small, pouch that branches off the left atrium) could be a godsend to millions of patients suffering from atrial fibrillation (AF) who are taking lifelong anticoagulant drugs. AF affects more than four million Americans, and worldwide that number is expected to rise to 16 million by 2050.

LAA closure devices fall into two basic categories: epicardial devices used during surgical procedures that are designed to close the LAA using sutures or other technologies applied to the LAA...

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