Sorin Group a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the Health Canada Therapeutic Products Directorate (TPD) approval to market the REPLY™ family of dual and single chamber rate adaptive pacemakers.
The REPLY pacemaker is the world’s smallest dual chamber pacemaker at only 8cc’s with no compromise on longevity. The smaller size enhances Sorin Group’s history of innovative technology.
REPLY integrates Sorin Group’s new proprietary SafeR™ pacing mode, based on the proven AAISafeR™ pacing mode first introduced to North America in 2005. Designed to titrate ventricular pacing, SafeRswitches 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. The CAN-SAVE R trial, currently being conducted in 10 centres across Canada, demonstrated that SafeR was able to reduce ventricular pacing to less than 1% in the overall population, ranging between 0% in patients without AV block and 1% in patients with AV block2 (median values).
In addition to SafeR, the REPLY pacemaker delivers enhanced software for advanced, automatic features such as SmartCheck™, which lets the user automate follow up tests, as well as providing comprehensive data reporting, analysis and recommendations.
Dr. Felix Ayala-Paredes, Chief of Electrophysiology Services at CHUS-Fleurimont Hospital in Sherbrooke Quebec, implanted the first REPLY pacemaker in Canada. “Recent Device-Based Therapy Guidelines highlight the new standard of care which is to minimize unnecessary ventricular pacing. The REPLY pacemaker was a good choice for this patient. I am confident that the SafeR algorithm will minimize ventricular pacing and I am especially impressed with the combination of small size and longevity.”
“After successful market introductions in Europe, Japan and the US, we are pleased to make the world’s smallest pacemaker featuring our exclusive SafeR technology available to Canadian physicians and patients. Building on Sorin’s legacy of innovations in Cardiac Rhythm Management, REPLY and SafeR promote the patient’s natural heart function by reducing unnecessary ventricular pacing. The availability of the REPLY pacemaker family in Canada underscores Sorin Group’s commitment to continuously improve the treatment of cardiac patients”, said Stefano Di Lullo, President of Sorin Group Cardiac Rhythm Management Business.
1. Pioger G, Leny G., Nitzsche R; Ripart A. AAIsafeR Limits Ventricular Pacing in Unselected Patients. PACE 2007; 30: S66-S70.
2. Thibault B. et al. Impact of AV Conduction Disorders on SafeR Mode Performance. PACE 2009; 32: S231-S235.
About the Sorin Group
The Sorin Group (www.sorin.com), is a global medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,500 employees worldwide, the Group focuses on three major therapeutic areas that include: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over 1 million patients are treated with the devices of Sorin Group in more than 80 countries.
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