Sorin Group announced that the company received Japanese approval to market the FACIL and REPLY families of dual and single chamber rate responsive pacemakers from Ministry of Health, Labor and Welfare (MHLW).
The FACIL and REPLY families encompass the latest Sorin Group bradycardia platform. The FACIL pacemaker is an 8cc device, with no compromise on longevity. With the addition of SafeR, REPLY is able to provide the complete range of therapies in FACIL. SafeR is 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.
Dr. Kei Tawarahara (Cardiovascular Division of Hamamatsu Redcross Hospital, Tokyo, Japan) implanted the first FACIL pacemaker in Japan on March 1st, 2009.
The FACIL pacemaker will leverage the success of the REPLY family, first implanted in Japan, by Dr. Yuji Nakazato, Professor of Cardiology at Juntendo University Hospital. Dr. Nakazato commented: “The 2007 ESC Guidelines on cardiac pacing and the 2008 ACC/AHA/HRS Guidelines for Device-Based Therapy emphasize the importance of reducing unnecessary ventricular pacing. The REPLY pacemaker with SafeR is able to promote the natural rhythm of this patient, reducing ventricular pacing to a very low percentage. The combination of SafeR, automatic features and good longevity all inside an 8cc pacemaker makes this device the most suitable choice for most of my patients.”
In September 2003, SafeR technology was introduced for the first time in Europe with AAISafeR, which has been shown to reduce unnecessary ventricular pacing in both Sinus Node Disease and unselected AV Block patients. Unnecessary pacing in the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation.
“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”, said Stefano Di Lullo, President of Sorin Group Cardiac Rhythm Management Business.
Japan Lifeline Co. Ltd. will distribute REPLY and FACIL pacemakers in JAPAN.