News | Left Atrial Appendage (LAA) Occluders | November 20, 2015

Boston Scientific Receives CE Mark For Next-generation Watchman FLX LAA Closure Device

First implants occur in Europe, commencing limited market release

Boston Scientific, Watchman FLX, LAA closure device, CE mark, first European implants

November 20, 2015 — Boston Scientific announced the first implants of the Watchman FLX left atrial appendage closure (LAAC) device – the latest generation of the Watchman device – occurred in Europe following CE mark approval.

Watchman FLX device implants were performed last week by Horst Sievert, M.D., department head of cardiology and vascular medicine, Sankt Katharinen Hospital, in Frankfurt, Germany; by Vivek Reddy, M.D., director of cardiac arrhythmia services for The Mount Sinai Hospital, at Na Homolce Hospital in Prague, Czech Republic; and Saibal Kar, M.D., director of cardiovascular intervention center research at Cedars-Sinai Heart Institute, at MC Medicor in Izola, Slovenia.

The Watchman FLX LAAC device is a catheter-delivered heart implant designed to close the LAA in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF. 

"The closed-end design of the Watchman FLX device and the ability to fully recapture and reposition this device make it a very promising option for treating indicated patients with simple to the most complex anatomies," said Sievert. "With nearly a decade of experience implanting the original Watchman device, it has been exciting to see the advancements of this technology from Boston Scientific and take part in the first implants of this device in Europe."

The first-generation Watchman device was CE marked in 2005 to prevent thrombus embolization from the LAA and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation (AF) who are eligible for anticoagulation therapy. In 2012 the CE Mark indication was expanded to include those who have a contraindication to anticoagulation therapy. AF affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently. Patients with AF have an increased risk of stroke due to the migration of clots formed in the LAA. 

This approval marks the second significant regulatory and commercial milestone for the Structural Heart business of Boston Scientific this year, following the U.S. Food and Drug Administration (FDA) approval of the first-generation Watchman device in March 2015. In the United States, the Watchman device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with: non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores; are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

Commercialization of the Watchman FLX device is currently in a limited market release and will become more widely available to approved EU countries in the first half of 2016. The device is not available for sale in the United States.

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