Sorin Group announced MHLW approval to market FACIL and REPLY pacemakers in Japan


Sorin Group, leader in the treatment of cardiovascular diseases, announced the Ministry of Health, Labor and Welfare approval to market the FACIL and REPLY families of dual and single chamber rate responsive pacemakers. The FACIL and REPLY families are based on the latest Sorin Group bradycardia platform.

The FACIL pacemaker is an 8cc device, with no compromise on longevity. REPLY offers the complete range of therapies in FACIL with the addition of SafeRTM, the first algorithm able to switch between AAI (atrial-based pacing) and DDD (dual chamber pacing) modes. Both pacemaker families offer advanced therapy options for atrial fibrillation (AF) prevention, recommendations for optimal programming of the system, innovative functions to automate implant and follow-up procedures, and functions specifically designed for patient safety.

Stefano Di Lullo, President of Sorin Group Cardiac Rhythm Management Business said, SafeR technology was first introduced in Europe in September 2003 with AAISafeR, which has been shown to reduce unnecessary ventricular pacing in both Sinus Node Disease and unselected AV Block patients.1 Unnecessary pacing in the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation.2 “The REPLY and FACIL families, based on Sorin Group’s latest generation pacing platform, bring the best of our bradycardia technology to the market and offer a complete range of options for the treatment of bradycardia patients in Japan. Thanks to the REPLY and FACIL families, Sorin Group reinforces its commitment to enhance the standard of care through improved therapies and the delivery of innovative technology in Cardiac Rhythm Management.