Dec 11 An advisory panel of medical experts
voted on Wednesday to recommend that U.S. health regulators
approve an experimental stroke-prevention device made by Boston
The panel voted 13 to 1 that the benefits outweigh the risks
of the Watchman device. The committee advised the U.S. Food and
Drug Administration to approve the Watchman for the prevention
of ischemic stroke and systemic embolism in patients with a
dangerous cardiac rhythm known as atrial fibrillation.
People with atrial fibrillation, the most common type of
arrhythmia, are five times more likely to suffer a stroke than
those without the condition. It affects nearly 3 million people
in the United States, and that number is expected to increase.
The FDA typically follows the recommendations of its expert
advisory panels, but is not obligated to do so.
In documents prepared before the committee meeting, FDA
staff members highlighted the implant's failure to meet a key
goal for effectiveness in a recent study. But they said other
data must be weighed in deciding whether it should be approved.
The device, implanted in the heart to prevent stroke in
patients with atrial fibrillation, was developed as an
alternative to clot-preventing blood thinners.
It is aimed at sparing heart patients a lifetime of taking
anticoagulant drugs, such as warfarin, which carry a high risk
An FDA advisory panel recommended approval of the
first-of-its-kind device in 2009, but the agency ultimately
decided another study was needed to evaluate its safety and
Boston Scientific acquired the Watchman device when it
bought Atritech in March 2011. It has been on the market in
Europe since 2005.