AGA Medical Holdings Inc. (NSDQ:AGAM) received federal approval to begin a clinical trial of a heart device designed to prevent stroke in patients with abnormal heartbeats.
The trial is intended to evaluate the safety and efficacy of the company’s Amplatzer cardiac plug in preventing blood clots in the heart that can lead to strokes. The trial will be conducted with patients suffering from atrial fibrillation, a condition in which the heart quivers and doesn’t pump blood properly. That can cause clots that travel to the brain and result in strokes, according to a statement from the company.
The study, if successful enough to get the device past the Food & Drug Administration, could boost sales for the cardiac plug by opening up the world’s largest market for medical devices. The Amplatzer product won CE Mark approval in the European Union in December 2008 and is also sold in South America and parts of Asia, according to the company.
AGA makes devices that treat structural heart defects and vascular problems. For the quarter ending Dec. 31, 2009 — its first as a publicly-traded entity — AGA exceeded analysts’ expectations, posting a $7 million profit on sales of $54 million. Revenues got a boost from the European launchof a vascular plug from AGA’s Amplatzer product line, CEO John Barr said in a statement last month.