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Sorin Receives FDA Approval For Paradym CRT model 8750

Sorin Group, a global leader in the treatment of cardiovascular disease, has reported the FDA approval and first implant of its cardiac resynchronization therapy defibrillator (CRT-D), Paradym CRT model 8750.

The company said that featuring a new, 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 antitachyarrhythmia 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.

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.

Dwight Reynolds, chief of the cardiovascular section at the University of Oklahoma Health Sciences Center in Oklahoma City, who performed the first US implant of Paradym CRT, said: “I’m impressed with the Sorin technology. 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 shock that is important to both my patients and myself.”

Stefano Di Lullo, president of the CRM business unit, said: “Sorin Group is proud to announce the US market release of Paradym CRT. This approval, combined with the first worldwide enrollment into our Clepsydra clinical trial, also occurring in the US, demonstrates our commitment to the US market and the strengthening of our innovative leadership in the hemodynamic management of heart failure.”