ELA Medical Receives FDA Clearance For Pacing Technology That Reduces Unnecessary Ventricular Pacing

ELA Medical, a Sorin Group Company and innovative leader in the development of cardiac rhythm management (CRM) implantable and diagnostic systems, announced today it received U.S. Food and Drug Administration (FDA) clearance for its new AAIsafeR(TM) 2 pacing mode. AAIsafeR 2 is ELA Medical's second-generation pacing mode that prevents unnecessary ventricular pacing, and is the first therapeutic-pacing alternative available in the United States. AAIsafeR 2 technology will be on display in ELA Medical's booth (#1215) at HEART RHYTHM 2005, the Heart Rhythm Society's Annual Scientific Sessions, being held May 4-7, 2005 in New Orleans.

Several recent clinical studies show that unnecessary right ventricular pacing increases a patient's risk of developing heart failure and atrial fibrillation. ELA Medical's Symphony(R) pacemakers, with AAIsafeR 2 mode, limit unnecessary ventricular stimulation to 0.1 percent in patients while they are not in heart block(1). Conventional pacemakers unnecessarily pace these same individuals 50-80 percent of the time.

ELA Medical's first-generation AAIsafeR pacing technology was launched in its Symphony pacing systems in September 2003 in Europe. The company received CE Mark earlier this year for its AAIsafeR 2 pacing technology.

"The ideal amount of unnecessary ventricular pacing is zero percent," said Malcolm Bersohn, M.D., Ph.D., electrophysiologist and professor of medicine at the University of California Los Angeles (UCLA) Medical Center. "AAIsafeR 2 is a promising technology because it comes remarkably close to meeting this objective. As a result, patients with intermittent heart block will experience both the benefits of atrial pacing and the safety of ventricular stimulation, if needed. AAIsafeR 2 will offer a dramatic reduction in ventricular pacing for a high percentage of patients."

Heart block is a disturbance of the heart's electrical conduction system that results in the inability of the heart's chambers to beat in sync. Three broad categories or degrees of heart block can occur. AAIsafeR 2 is the only algorithm that can detect and manage all three degrees of heart block. An estimated 60 percent of the pacemaker population can benefit from AAIsafeR 2 pacing(2). No other pacemaker can treat such a large patient population.