Dec 9 (Reuters) - Boston Scientific Corp’s anti-stroke device did not meet one measure of success in a clinical study of the implant, but other data must be considered when determining overall safety and effectiveness, staff members of the U.S. Food and Drug Administration stressed on Monday.
FDA released documents about the implant, called Watchman, ahead of a meeting Wednesday of outside medical experts who will review the device and recommend whether it should be approved for use in the United States.
The device, implanted on the heart to prevent stroke in patients with a dangerous cardiac rhythm known as atrial fibrillation, was developed as an alternative to clot-preventing blood thinners. If approved, it could potentially spare heart patients a lifetime of taking anticoagulant drugs, such as warfarin, that carry a high risk of bleeding.
Boston Scientific acquired the Watchman device when it bought Atritech in 2011. It has been on the market in Europe for several years.