Cardiology, business  

Sorin Group receives approval for world's smallest implantable cardioverter defibrillator

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.

An implantable 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 longevity.

To significantly reduce patient follow-up time, OVATIO ICDs are supported by completely new programming software, which is ten times faster than previous versions.

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