US Clinical Trial Begins for AGA's Amplatzer Cardiac Plug

June 16, 2010—AGA Medical Corporation (Plymouth, MN) announced the commencement of enrollment in the feasibility phase of the prospective, multicenter, randomized clinical trial of the company's Amplatzer cardiac plug in the United States. The study is evaluating the safety and efficacy of the device to close the left atrial appendage and prevent stroke in atrial fibrillation patients compared to warfarin. The Amplatzer cardiac plug received CE Mark approval in December 2008 and is currently sold in Europe, South America, and parts of the Pacific Rim. William Nicholson, MD, enrolled the trial's first patient at York Hospital in Pennsylvania.

"The Amplatzer cardiac plug represents the next generation of left atrial appendage closure devices, with a novel design that leverages the proven and easy-to-use Amplatzer technology," commented Dr. Nicholson. "Many patients struggle with the effects and regimen of warfarin, and I am hopeful that atrial fibrillation patients may have an alternative with the Amplatzer cardiac plug to prevent stroke."