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Sorin's Ovatio CRT family receives US FDA approval

Sorin : 19 May, 2008  (New Product)
The Sorin Group has received US Food and Drug Administration's approval to market the CRT model of the company’s Ovatio family.
Coupled together with the Situs OTW left ventricle pacing lead, this device will now allow US physicians to treat their heart failure patients with a complete Sorin Group system.

Ovatio CRT 6750, the smallest CRT defibrillator (CRT-D) available worldwide (30cc, 11mm) is shaped to offer ease of implantation and long-term patient comfort, and is designed to allow more flexibility in the management of cardiac resynchronization and anti-tachyarrhythmia therapy, thanks to a unique feature: Brady-Tachy Overlap (BTO).

Maintaining CRT during exercise, including at elevated heart rates, might allow the patient to experience prolonged, and eventually, beneficial physical activity. However heart failure patients present a high incidence of 'slow' ventricular tachycardias (VT) which heart rates coincide with exercise rates. These arrhythmias have been reported to cause significant clinical effects.

Managing these conflicting aspects is challenging and usually either CRT delivery has to be favoured at the expense of slow VTs protection, or inversely. Ovatio CRT's BTO feature is designed to ‘Unlock Pacing and Detection’, to ensure delivery of resynchronization therapy during exercise without any compromise on the management of slow VTs.

“I like the fact that with the smallest CRT-D in the world I can resynchronize my patients during maximal exercise as well as detect and treat slower ventricular tachycardias without programming constraints”, stated Dr Michael R Gold, Medical University of South Carolina, Charleston, South Carolina (USA).

Moreover, Ovatio CRT performs best-in-class detection of arrhythmia thanks to P And R Arrhythmia Detection (PARAD/PARAD+). Studies demonstrated that PARAD+ has a superior specificity in discriminating atrial from ventricular arrhythmias: the absolute risk of experiencing an inappropriate shock has been observed to be only five percent, the lowest percentage reported thus far. For heart failure patients it is crucial that life saving therapies are delivered when necessary, and only when necessary, to improve quality of life.

'The Ovatio CRT-D system completes the range of Sorin Group defibrillators available in the US, in addition to Ovatio single- and dual-chamber defibrillators and to the Isoline defibrillation lead. It is a big step towards strengthening our position in the US by entering the $2 billion CRT segment and offering a complete solution to patients and physicians”, said Fred Hrkac, president of Sorin Group Cardiac Rhythm Management (CRM) Business Unit.

The Ovatio CRT will be distributed in the USA by ELA Medical, a Sorin Group company.
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