Sorin releases new Paradym CRT defibrillator
9 February 2010
Sorin Group (MIL:SRN) (Reuters Code: SORN.MI) has announced
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, one of the highest energy levels of implantable
cardiac defibrillators (ICD) on the market. In addition, it offers
consistent charge times throughout the life of the device.
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 US 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 US, demonstrates our commitment to the US market and the
strengthening of our innovative leadership in the hemodynamic management
of heart failure.”