News | June 17, 2010

First Patient Enrolls in Prospective Cardiac Plug Trial

June 17, 2010 – AGA Medical Holdings Inc. this week announced first patient enrollment in the feasibility phase of the prospective, multicenter, randomized Amplatzer Cardiac Plug clinical trial. William Nicholson, M.D., an interventional cardiologist and structural heart specialist at York Hospital in Pennsylvania, enrolled the first patient in this multicenter, randomized trial.

Scientific data have demonstrated that atrial fibrillation (AF) patients are five times more likely to suffer a stroke without treatment than those who do not have the heart arrhythmia. These strokes are linked to the left atrial appendage – a small structure off the left atrium of the heart — where blood can pool. The current standard of care is to treat these patients with anticoagulants (warfarin), which are difficult to tolerate for many people and carry a risk of serious complications, such as bleeding. This clinical study is evaluating the safety and efficacy of the Amplatzer Cardiac Plug to close the left atrial appendage and prevent stroke in AF patients compared to warfarin, the most prescribed blood-thinning medication.

“Many patients struggle with the effects and regimen of warfarin, and I am hopeful that AF patients may have an alternative with the Amplatzer Cardiac Plug to prevent stroke,” said Dr. Nicholson. “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.”

An estimated 2.3 million Americans have AF, and the likelihood of developing it increases with age. In the United States, 3 to 5 percent of people over the age of 65 have the arrhythmia. AF can cause blood to pool in the left atrial appendage, increasing the chance of clots that may travel to the brain and lead to stroke.

The Amplatzer Cardiac Plug received European CE mark approval in December 2008, and is currently sold in Europe, South America and parts of the Pacific Rim.

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