AGA Medical today announced first patient enrollment in the feasibility phase of the prospective, multicenter, randomized AMPLATZER(R) Cardiac Plug clinical trial. Dr. William Nicholson, an interventional cardiologist and structural heart specialist at York Hospital in Pennsylvania, enrolled the first patient.
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.
President and chief executive officer of AGA Medical John Barr commented, "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," Barr continued.
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.
About AGA Medical
AGA Medical, based in Plymouth, Minnesota, is a leading innovator and manufacturer of medical devices for the treatment of structural heart defects and vascular abnormalities. AGA Medical's AMPLATZER(R) occlusion devices offer minimally invasive, transcatheter treatments that have been clinically shown to be safe and highly effective in defect closure. AGA Medical is the only manufacturer with occlusion devices approved to close seven different structural heart defects, with leading market positions for each of its devices. More than 1,650 articles supporting the benefits of AMPLATZER products have been published in medical literature. AGA Medical markets its AMPLATZER products in 112 countries worldwide to interventional cardiologists, electrophysiologists, interventional radiologists and vascular surgeons.
Source: AGA Medical Holdings, Inc.
