AGA Medical has received federal approval to begin a clinical trial of a heart device that’s designed to prevent strokes 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 trials, if successful, could eventually lead to federal approval that would allow AGA to begin marketing the device in the U.S. Food and Drug Administration approval could boost sales for the cardiac plug by opening up the world’s largest market for medical devices. The cardiac plug won regulatory approval for sales in Europe in December 2008 and is also sold in South America and parts of Asia, according to the company.
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AGA focuses on selling devices that treat structural heart defects and vascular problems. The end of 2009 marked the completion of AGA’s first quarter as a public company. For the quarter ending Dec. 31, 2009, AGA exceeded analysts’ expectations, posting a $7 million profit on sales of $54 million. Sales were helped by the European launch of a vascular plug from AGA’s Amplatzer product line, CEO John Barr said in a statement last month.
