Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology

 News Release - February 5, 2010

Sorin Group Announces Market Release and First Implant of Next-Generation Cardiac Resynchronization Therapy Defibrillator

New PARADYM™ CRT Model 8750 is the World’s Highest Output Device Delivering 37J of Energy Quickly and Accurately

MILAN--(HSMN NewsFeed)--Sorin Group (MIL:SRN) (Reuters Code: SORN.MI), a global leader in the treatment of cardiovascular disease, announced today U.S. FDA approval and first implant of its next-generation of Cardiac Resynchronization Therapy defibrillator (CRT-D), Paradym™ CRT Model 8750. Featuring a new, state-of-the-art battery technology, Paradym™ CRT delivers 37 Joules, the highest energy of any implantable cardiac defibrillator (ICD) currently available. In addition, Paradym™ offers consistent charge times throughout the life of the device (10s at Beginning Of Life, 13s at Elective Replacement Indicator - ERI), improved longevity, and a 6-month ERI to End of Service (EOS) period, twice as long as any other ICD.

Paradym™ CRT is designed to allow more flexibility in the management of cardiac resynchronization and anti-tachyarrhythmia therapy in heart failure patients. BTO (Brady-Tachy Overlap) is designed to unlock pacing and detection to ensure delivery of resynchronization therapy at high pacing rates during exercise without any compromise on the management of slow ventricular tachycardias (VTs). BTO gives freedom of programming for physicians.

“I’m impressed with the Sorin technology”, said Dr. Dwight Reynolds, chief of the Cardiovascular Section at the University of Oklahoma Health Sciences Center in Oklahoma City, OK who performed the first US implant of Paradym CRT. “They have managed to pack a lot of power into a small can without compromising on features, good charge times or longevity. I especially like the six months longevity post-ERI and the PARAD+ discrimination algorithm to minimize inappropriate shocks…that is extremely important to both my patients and myself.”

Paradym™ CRT, at 34cc and 11mm thin, also features the PARAD®+ detection algorithm whose superior specificity in discriminating ventricular arrhythmias has been clinically proven. Studies have demonstrated that the absolute risk of experiencing an inappropriate shock has been observed to be only 5%, the lowest percentage recorded thus far.

Stefano Di Lullo, President of the CRM business unit commented: “Sorin Group is proud to announce the U.S. market release of Paradym CRT. This approval, combined with the first worldwide enrollment into our CLEPSYDRA (evaluating the effectiveness of the PhD Clinical Status Monitoring feature to detect HF events) clinical trial, also occurring in the U.S., demonstrates our commitment to the U.S. market and the strengthening of our innovative leadership in the hemodynamic management of heart failure.”

About Sorin Group

Sorin Group, 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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Source: Sorin Group

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