Dec 9 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