CE Mark Approved for Boston Scientific's Next-Generation Watchman FLX LAA Closure Device

November 19, 2015—Boston Scientific announced European CE Mark approval for the Watchman FLX left atrial appendage (LAA) closure device. Commercialization of the Watchman FLX device is currently in a limited market release and will become more widely available to approved European Union countries in the first half of 2016. The Watchman FLX device is not available for sale in the United States, advised the company.

According to Boston Scientific, the Watchman FLX device is a catheter-delivered heart implant designed to close the LAA and prevent the migration of blood clots. This reduces the incidence of stroke and systemic embolism for higher risk patients with nonvalvular atrial fibrillation.

Last week, the first Watchman FLX implantation procedures were performed by Horst Sievert, MD, at Sankt Katharinen Hospital in Frankfurt, Germany; Vivek Reddy, MD, at Na Homolce Hospital in Prague, Czech Republic; and Saibal Kar, MD, at MC Medicor in Izola, Slovenia. 

Dr. Sievert is Department Head of Cardiology and Vascular Medicine at Sankt Katharinen Hospital. Dr. Reddy is Director of Cardiac Arrhythmia Services for Mount Sinai Hospital in New York, New York. Dr. Kar is Director of Cardiovascular Intervention Center Research at Cedars-Sinai Heart Institute in Los Angeles, California.

In the company’s press release, Dr. Sievert commented, “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.” He added, “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.”

Boston Scientific noted that the first-generation Watchman device received CE Mark approval in 2005 to prevent thrombus embolization from the LAA and reduce the risk of life-threatening bleeding events in patients with nonvalvular atrial fibrillation who are eligible for anticoagulation therapy. In 2012, the CE Mark indication was expanded to include those patients who have a contraindication to anticoagulation therapy.