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News

Sorin Group has launched in Japan of the world's smallest line of ICDs

Sorin : 31 August, 2007  (New Product)
The single chamber and dual chamber models Ovatio VR 6250 and DR 6550 ICD have received regulatory and reimbursement approval from the Ministry of Health, Labor and Welfare.
Both ICD models are immediately available.

First Implant of Ovatio was successfully performed by Dr Morio Shoda MD, associate professor, Department of Cardiology, Tokyo Women's' Medical University Hospital.

Dr Shoda declared: 'The Implant procedure was completed smoothly. The shape and size of Ovatio DR fits Japanese patients, especially its thinness is beneficial. Also, its discrimination algorithm for tachyarrhythmia (PARAD+), three detection zones with ATP and brady pacing overlapping programmability are unique features which provide the physician with a broader choice for each patient. Technology to reduce ventricular pacing is an essential feature for the best therapy in arrhythmia management'.

An ICD is an implantable device designated to detect a life-threatening, rapid heartbeat - a ventricular tachyarrhythmia - coming from the lower chamber of the heart. It rapidly converts the abnormal rhythm back to normal by delivering anti-tachycardia pacing pulses or an electrical shock to the heart.

The advanced device can prevent sudden cardiac arrest, the leading cause of death in Japan with an estimated 80,000 deaths each year.

The Ovatio ICD family includes innovative features dedicated both to pacing and arrhythmia management. Dual chamber Ovatio DR includes two features: SafeR and PARAD+.

SafeR promotes natural heart activity by reducing unnecessary stimulation in the right ventricle. Studies suggest that this reduction could decrease the risk of heart failure and atrial fibrillation, both of which can prove fatal.

The patient's AV conduction can fully be documented through detailed event recordings and intracardiac EGMs (IEGMs). SafeR reduces the amount of ventricular pacing to less than 0.2 percent in 80 percent of ICD patients with intrinsic conduction compared to up to 50 percent for unselected conventional dual chamber patients. SafeR pacing technology has been available in Europe since September 2003.

PARAD+ is intended to protect patients from inappropriate shocks which can result from misclassified supraventricular tachyarrhythmias (SVTs) and sinus tachycardias (STs). While SVTs and STs have been reported to trigger 55 percent to 69 percent inappropriate shocks, PARAD+ demonstrated a 99 percent overall specificity to these arrhythmias with out-of-the-box settings , drastically reducing the number of inappropriate shocks.

'With the Ovatio DR launch we are expecting to set the standard for ICDs. Such devices will benefit many patients who would otherwise suffer a potential disadvantage. The launch of Ovatio, the world's smallest defibrillator, in Japan is a testament of our commitment to continuously improve patient comfort. Sorin Group extends its contribution to the Japanese arrhythmia management market,' said Sumio Sugiyama, general manager, Sorin Japan.
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