A group of physicians assembled Tuesday on behalf of the FDA to rule that St. Jude Medical's new heart device appears safe and effective in stroke prevention, according to the Minneapolis Star Tribune.

The Amplatzer PFO Occluder has undergone more than 13 years of U.S. clinical research. In a 15-1 vote, physicians on the panel stated that the long-running trials produced a reasonable assurance that the device is safe for use. The physicians voted 11-5 that its benefits outweigh its risks, and 9-7 that the device is effective for its intended use.

Ischemic strokes are one of the leading causes of disability in the United States. The new device aims to help the 16,000 stroke patients a year who also have a hole in the upper chambers of the heart, known as a patent foramen ovale.

St. Jude's PFO Occluder is made of two wire-mesh discs, which are placed inside the heart, allowing physicians to seal off the hole from both sides and prevent blood flow directly between the two upper chambers of the heart. The device is minimally invasive and implanted via a catheter in the leg as opposed to open-heart surgery.

During its presentation to the FDA, St. Jude said the study showed a 63 percent relative reduction in risk of stroke compared to medical therapy.