Sorin Group receives approval for world's smallest implantable
30 May 2006
Boston, USA. ELA Medical, part of Italian company Sorin
Group (MIL:SRN), has received approval from the US Food and Drug
Administration (FDA) to market its new family of a dual and single chamber
implantable cardioverter defibrillators (ICDs).
At only 29cc, the company
claims its Ovatio DR is the world's smallest dual-chamber ICD. For ICD
patients, having the smallest possible device implanted is important both
for comfort and cosmetic reasons.
cardioverter-defibrillator is designed to quickly detect ventricular
arrhythmias — life-threatening rapid heartbeats that come from the heart's
lower chambers. ICDs can prevent sudden cardiac arrest, which kills an
estimated 325,000 people in the U.S. each year.
The company says that the
AAIsafeR pacing mode limits unnecessary pacing in the right ventricle, which
studies suggest may increase the risk of heart failure and atrial
fibrillation, both of which can prove fatal in addition to imposing a heavy
cost burden on the healthcare system. Studies show that ventricular pacing
was reduced to only 0.2% when AAIsafeR mode was used in Ovatio DR patients
with intact conduction.
"With this combination, we can address patients
with all types of heart block while offering the most specific algorithm for
arrhythmia detection," said Dr. Ken Ellenbogen, professor of medicine and
director of the Electrophysiology and Pacing Laboratory at Virginia
Commonwealth University Medical Center in Richmond, Va.
With Parad+, its
enhanced and fast discrimination of ventricular tachyarrhythmia, the Ovatio
family is also capable of detecting and treating the full spectrum of
ventricular tachyarrhythmias, i.e., slow (100 beats per minute) and fast (up
to 255 beats per minute), through painless anti-tachycardia pacing (ATP).
ATP is delivered as first-line therapy, thus sparing the patients
unnecessary defibrillation shocks that could decrease the device's
To significantly reduce patient follow-up time, OVATIO ICDs are
supported by completely new programming software, which is ten times faster
than previous versions.