Boston Scientific Wins CE Mark for Watchman FLX

Boston Scientific has won the CE mark for its next-generation Watchman FLX left atrial appendage closure device.

The device is a catheter-delivered heart implant designed to close the left atrial appendage to prevent the migration of blood clots from the LAA.  It aims to reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular atrial fibrillation.

The first implants of the device were performed at Sankt Katharinen Hospital in Frankfurt, Germany.

The Watchman FLX device is currently in a limited market release and will become more widely available in approved EU countries in the first half of 2016. — Michael Cipriano