FDA Panel Endorses BSX Anti-Stroke Device

Boston Scientific Headquarters in Natick

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A panel of medical experts recommended Wednesday that federal health regulators approve Boston Scientific’s stroke-prevention device.

The panel voted 13-1 that the benefits of the Natick-based company’s Watchman device outweigh its risk. The ruling applies to the device’s use in preventing ischemic stroke and systemic embolism in patients with atrial fibrillation, which can cause an irregular or fluttering heart beat.

Atrial fibrillation affects nearly three million people in the United States, with those suffering from the disease five times more likely to suffer a stroke than those without the condition.

“We are pleased with the outcome of today’s panel, which represents an important milestone toward making this innovative technology available to patients…at higher risk for stroke who need an alternative to long-term warfarin (blood thinning)therapy,” said Dr. Kenneth Stein, chief medical officer for the cardiac rhythm management division, in a statement.

The FDA is expected to make a final approval decision in the first half of 2014, Boston Scientific said.

The agency isn’t obligated to follow the recommendation of its advisory committees. An FDA panel recommended approval of the Watchman in 2009, but the agency ultimately decided another study was needed to evaluate its safety and effectiveness.

Documents released Monday by FDA staff said the surgery required to implant the Watchman might reduce its effectiveness and that its effectiveness was at times lower than blood thinners such as warfarin.

The Watchman would allow patients to avoid a lifetime of taking anticoagulant drugs like warfarin, which often lead to bleeding.

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