Sorin Group (Milan, Italy) has announced U.S. FDA approval and first implant of its next-generation of cardiac resynchronization therapy defibrillator (CRT-D), Paradym CRT Model 8750. According to the company, this is the world’s most powerful AICD, with a 37 Joule punch:
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.