AGA Medical Clinical Trial for Amplatzer Cardiac Plug Begins Enrolling Patients – Alternative to Warfarin Treatment For Atrial Fibrillation

Blood thinning Warfarin is always tough to regulate and the clinical trial in this case is to use the plug to close the left atrial area and hopefully prevent strokes with patients having atrial fibrillation. With the left side of the heart being connected to strokes perhaps the plug can make the difference.

The Cardiac Plug received European CE Mark approval in December 2008. BD

MINNEAPOLIS, Jun 16, 2010 (BUSINESS WIRE) -- AGA Medical Holdings, Inc. 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.