Boston Scientific has announced the first implants of the Watchman FLX Left Atrial Appendage Closure
Boston Scientific's Watchman FLX Left Atrial Appendage Closure device
The implantation of the Watchman FLX device, the latest generation of Boston Scientific’s Watchman devices, took place in Europe following CE mark approval.
Boston Scientific said the first-generation Watchman device prevented thrombus embolisation from the left atrial appendage (LAA) and reduced the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation (AF) who are eligible for anticoagulation therapy.
The more recent CE mark indication was expanded to include those who have a contraindication to anticoagulation therapy
Dr. Kenneth Stein, chief medical officer, rhythm management, Boston Scientific, said: "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."
The Watchman FLX device implants were performed by Dr Horst Sievert, Sankt Katharinen Hospital in Frankfurt, Dr Vivek Reddy, Mount Sinai Hospital, at Na Homolce Hospital in Prague and Dr Saibal Kar, Cedars-Sinai Heart Institute, at MC Medicor in Izola.
Sievert said: "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."