The US Food and Drug Administration has given approval to the REPLY™ family of dual and single chamber pacemakers from the Italian firm The Sorin Group. Our initial reporting about these device was back in March of this year, after EU’s regulators approved the firm’s 8cc device for marketing in the European Union. (See REPLY, World’s Smallest Pacemaker OK’ed in Europe)
The following statement was just issued by the company:
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 proven AAISafeR™ pacing mode first introduced in Europe in September 2003 and in the US 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 patients1. Delivering unnecessary pacing to the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation2.
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.
“The REPLY pacemaker delivers to the market Sorin Group’s 2nd 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 Group Cardiac Rhythm Management Business.
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 US. “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. Reply provides the output, longevity and pacing algorithms that physicians are looking for in a pacemaker.”
The REPLY pacemaker will be distributed in the United States by ELA Medical, Inc., a Sorin Group Company.