In a promising development for Plymouth-based Atritech Inc., a Food and Drug Administration panel of experts voted 7-5 Thursday to recommend approval of the company's new device to treat a common heart condition called atrial fibrillation.
Device-based treatments for atrial fibrillation represent a new frontier in medical technology, since the condition afflicts some 6.5 million people worldwide. Atrial fibrillation involves abnormal quivering of the upper chambers of the heart.
Atritech's Watchman device, nine years in the making, is placed near the heart during an angioplasty-like operation and prevents blood clots from entering a patient's bloodstream and causing a stroke. The Watchman would be a breakthrough product for the small, privately held company.
The FDA is not bound by the panel's recommendation, but in most cases the agency follows the panel's advice.
"It's a great victory for us," said Atritech CEO Jim Bullock. "Hopefully we'll get final approval and then we'll commercialize within a few months."
Typically, patients who suffer from atrial fibrillation take blood-thinning medications to prevent clots from forming, but these drugs often have side effects such as internal bleeding.
Atritech, which has raised $75 million from investors, released results from an 800-patient study at an American College of Cardiology scientific meeting last month. The study pitted the Watchman device against the widely used blood-thinning drug warfarin.
Earlier this week, however, FDA staff released a memorandum citing concerns about the relatively short length of the study and the types of patients enrolled.
