Boston Scientific (NYSE:BSX) said today it won CE Mark approval in the European Union for its Watchman FLX left atrial appendage closure device, and announced the device has been successfully implanted in its 1st set of patients.
The 1st Watchamn FLX devices were implanted last week by Dr. Horst Sievert of Frankfurt, Germany’s Sankt Katharinen Hospital, Dr. Vivek Reddy of Mt. Sinai Hospital in Prague’s Na Homolce Hospital and by Dr. Saibal Kar of Cedars-Sinai Heart Institute at Izola, Slovenia’s MC Medicor, Marlborough, Mass.-based Boston Scientific said.
“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,” rhythm management chief medical officer Dr. Kenneth Stein said in a press release.
The Watchman FLX is currently only commercialized in a limited market, Boston Scientific said, and will be expanded to wider availability to approved EU countries in the 1st half of 2016.
“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,” Dr. Sievert said in prepared remarks.
The original Watchman device won CE Mark approval in 2005 to prevent thrombus embolization, and was expanded in 2012 to include patients with a contraindication to anticoagulation therapy.
In March, the company’s 1st generation Watchman anti-stroke device won FDA approval, 6 years after an FDA advisory panel 1st recommended approval for the heart implant.
Boston Scientific said March 13 that the pre-market approval nod is for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy.