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 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.
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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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