A Medical Device Daily
The Sorin Group (Denver) has received FDA approval to market the Reply family of dual and single-chamber pacemakers.
Reply combines Sorin's new SafeR pacing mode, SafeR technology building on the AAISafeR pacing mode introduced in Europe in September 2003 and in the U.S. in May 2005.
AAISafeR switches from AAI to DDD in case of AV block detection, and has been shown, Sorin said, to reduce unnecessary pacing in both sinus node disease and unselected AV block patients. Delivering unnecessary pacing to the right ventricle has been shown to increase the risk of patients developing heart failure and atrial fibrillation.
In addition to SafeR, the Reply pacemaker delivers automatic features such as SmartCheck, which lets the user automate follow-up tests and provides comprehensive data reporting and recommendations.
"The Reply pacemaker delivers to the market Sorin Group's second-generation universal pacing platform built around our exclusive SafeR pacing mode. Reply and SafeR demonstrate Sorin Group's continued commitment to driving innovation in cardiac rhythm management and reinforces our mission to continuously improve the treatment of bradycardia," said Fred Hrkac, president of Sorin's Cardiac Rhythm Management Business.
The Sorin specializes in making cardiac surgery products.