Boston Scientific's Watchman FLX Left Atrial Appendage Closure Device Approved in Europe
March 13, 2019—Boston Scientific Corporation announced it has received European CE Mark approval of the next-generation Watchman FLX left atrial appendage closure (LAAC) device, which is intended to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (AF).
The company has begun a limited market release of the Watchman FLX device in Europe and expects to expand commercialization to additional sites in the second half of 2019. It also plans to begin enrolling European patients in a postapproval registry in the coming months.
According to Boston Scientific, the next-generation Watchman FLX device is designed for simplified implantation to fit a wider range of patients, from simple to the most complex anatomies. The device allows for implantation flexibility to customize placement with a fully enclosed and rounded frame, and by offering physicians the ability to fully recapture and reposition the device during the procedure. The frame of the new device is designed to enhance sealing within the left atrial appendage.
In the United States, the Watchman FLX device is an investigational device and is not available for sale, advised Boston Scientific.