FDA Clears ELA's Pacing Technology

ELA Medical, a Sorin Group company specializing in the development of cardiac rhythm management implantable and diagnostic systems, has received FDA clearance for its new AAIsafeR 2 pacing mode.

AAIsafeR 2 is ELA's second-generation pacing mode that prevents unnecessary ventricular pacing, and is the first therapeutic-pacing alternative available in the U.S. ELA's first-generation AAIsafeR pacing technology was launched in its Symphony pacing systems in September 2003 in Europe. The company received the CE Mark earlier this year for its AAIsafeR 2 pacing technology.

The AAIsafeR 2 pacing mode is already incorporated in previously implanted Symphony pacemakers. A software change to the pacemaker programmer unlocks this feature in thousands of patients who already have these devices implanted. Symphony pacemakers with AAIsafeR 2 limit unnecessary ventricular stimulation to 0.1 percent in patients while they are not in heart block. Conventional pacemakers unnecessarily pace these same individuals 50 percent to 80 percent of the time.