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.
“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 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.”
Study: 40% of newly diagnosed heart failure patients also have atrial fibrillation