AGA Medical, an US-based cardiovascular medical device company, has enrolled first patient in the feasibility phase of the prospective, multicenter, randomized Amplatzer Cardiac Plug clinical trial.
The clinical study evaluates the safety and efficacy of the Amplatzer Cardiac Plug to close the left atrial appendage and prevent stroke in atrial fibrillation (AF) patients compared to warfarin, the most-prescribed, blood-thinning medication.
AGA Medical said that the Amplatzer Cardiac Plug has received European CE mark approval in December 2008, and is currently sold in Europe, South America and parts of the Pacific Rim.
William Nicholson, an interventional cardiologist and structural heart specialist at York Hospital in Pennsylvania, enrolled the first patient, said: “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. 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.”
John Barr, president and chief executive officer of AGA Medical, said: “Beginning enrollment in this study is a significant milestone for AGA Medical. We believe that our device to close the left atrial appendage is an innovative solution to a complex and debilitating problem for patients and the health care system.
“With our first patient enrolled, we are advancing a study that demonstrates our continued commitment to developing high-value products that can change the standard of care for patients, as well as providing physicians with scientifically sound data.”