'The WATCHMAN Device is the most studied left atrial appendage closure device and has been used to help reduce the risk of stroke for tens of thousands of high-risk patients with non-valvular atrial fibrillation who seek an alternative to long-term anticoagulant therapy,' said Dr.
WATCHMAN FLX Device implants were performed last week by Dr.
'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 Dr. Sievert. 'With nearly a decade of experience implanting the original WATCHMAN Device, it has been exciting to see the advancements of this technology from
The first-generation WATCHMAN Device was CE-marked in 2005 to prevent thrombus embolization from the left atrial appendage (LAA) and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation (AF) who are eligible for anticoagulation therapy, and 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
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 WATCHMAN FLX Device is not available for sale in the U.S.
About the WATCHMAN FLX LAAC Device
The WATCHMAN FLX LAAC Device is a catheter-delivered heart implant designed to close the left atrial appendage (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 LAA is a thin, sac-like appendix arising from the heart and is believed to be the source of >90% of stroke-causing clots that come from the left atrium in people with non-valvular AF. Images of the WATCHMAN Device and the WATCHMAN FLX Device are available at http://news.bostonscientific.com/image-gallery.
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