(Reuters) - Boston Scientific Corp on Monday said it has temporarily stopped selling a newer version of its Watchman atrial fibrillation treatment in Europe due to a higher-than-expected rate of embolisms associated with the implant.
The FLX model, launched in some European markets in November, is a second-generation version of the Watchman device sold in the United States.
The implant is designed to prevent strokes in patients with a form of atrial fibrillation, or irregular heartbeat. The device works by sealing off the left atrial appendage where blood can pool and clot and allows patients to stop taking the blood thinner warfarin.
The company will look at whether physician training and implant technique are causing the higher-than-expected rate of device-related embolisms, Boston Scientific medical officers told an investor meeting at the American College of Cardiology scientific sessions in Chicago.
The rate is comparable to what the company saw when its current Watchman product was first released, they said.
Boston Scientific is the only company selling a left atrial appendage closure device in the United States. Watchman gained U.S. regulatory approval in March 2015.
Suspending Watchman FLX sales in Europe will not affect the company’s revenue forecast this year of $175 million to $200 million for its structural heart division that includes the device, company officials said.
The U.S. Heart Rhythm Society estimates more than three million Americans have atrial fibrillation, the most common type of arrhythmia. Patients with atrial fibrillation are five times more likely to suffer a stroke than those without the condition.
Reporting by Susan Kelly in Chicago; Editing by Alan Crosby
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