The next-generation Watchman left atrial appendage closure device (Watchman FLX) has received CE mark approval and the first implants of the Boston Scientific device have taken place in Germany, the Czech Republic and in Slovenia, commencing limited market release.
A press release reports that the implants were performed last week by Horst Sievert (Sankt Katharinen Hospital, Frankfurt, Germany), Vivek Reddy (The Mount Sinai Hospital in New York, USA) and by Saibal Kar (Cedars-Sinai Heart Institute, Los Angeles, USA). Reddy and Kar, respectively performed the implants at Na Homolce Hospital (Prague) in the Czech Republic and at MC Medicor (Izola) in Slovenia.
Sievert says: “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.”
According to a press release, the CE mark approval Watchman FLX marks the second significant regulatory and commercial milestone for the structural heart business of Boston Scientific this year, following the FDA approval of the first-generation Watchman device in March this year (2015). Commercialisation 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.