Sorin Group Announces FDA Approval and First U.S. Implant of the Smallest Implantable Dual Chamber Pacemaker: REPLY Pacemakers I

The Sorin Group announced the U.S. Food and Drug Administration’s (FDA) approval to market the REPLY™ family of dual and single chamber pacemakers. The REPLY pacemaker, the world’s smallest dual chamber pacemaker at 8cc’s, is Sorin Group’s next pacing evolution designed to reduce ventricular pacing and promote natural cardiac function. REPLY integrates Sorin Group’s new proprietary SafeR™ pacing mode. The SafeR technology builds on the Sorin Group's AAISafeR™ pacing mode first 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 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 significantly enhance the risk of patients developing heart failure and atrial fibrillation. In addition to SafeR, the REPLY pacemaker delivers advanced, automatic features such as SmartCheck™, which lets the user automate follow-up tests and provides comprehensive data reporting and recommendations. Dr. Randy Lieberman, Director of Electrophysiology at Harper University Hospital and Assistant Professor of Medicine at Wayne State University School of Medicine in Detroit implanted the first REPLY pacemaker in the United States. “The updated 2008 ACC/AHA Guidelines for Device-Based Therapy highlight the new standard of care in pacing, which is to minimize unnecessary ventricular pacing. The REPLY pacemaker was the right choice for this patient. Pacemaker options that only offer AV delay or AV search hysteresis do not eliminate frequent ventricular pacing for a significant number of patients. It’s important to know that down-sized devices do not mean that physicians have to compromise.” The REPLY pacemaker will be distributed in the United States by ELA Medical, Inc., a Sorin Group Company.