Boston Scientific, a worldwide developer, manufacturer and marketer of medical devices, has announced that the first implants of the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device have successfully been carried out in Europe following CE mark approval.
WATCHMAN FLX LAAC is the latest generation of the WATCHMAN Device. LAAC is a treatment to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF).
‘Boston Scientific has recently received marketing approval for its WATCHMAN FLX Left Atrial Appendage Closure Device in Europe. They have also successfully carried out the first implants of the LAAC.’
"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. We are pleased that this next-generation technology has been granted European regulatory approval and we can begin a controlled product roll-out to clinicians throughout Europe," said Dr. Kenneth Stein, chief medical officer, Rhythm Management, Boston Scientific.
The implants were performed last week by Dr. Horst Sievert, department head of Cardiology and Vascular Medicine, Sankt Katharinen Hospital, in Frankfurt, Germany; by Dr. Vivek Reddy, director of Cardiac Arrhythmia Services for The Mount Sinai Hospital, at Na Homolce Hospital in Prague, Czech Republic; and Dr. Saibal Kar, director of Cardiovascular Intervention Center Research at Cedars-Sinai Heart Institute, at MC Medicor in Izola, Slovenia.
"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. 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," said Dr. Sievert in a press release.