Healthcare Industry News:  Carbomedics 

Devices Cardiology Regulatory

 News Release - August 31, 2007

Sorin Group Launches World's Smallest Implantable Cardioverter Defibrillators in Japan

First implant of OVATIO(TM) DR Implantable Cardioverter Defibrillator (ICD) Performed by Leading Medical Institution

MILAN, Italy & TOKYO--(HSMN NewsFeed)--Sorin Group (MIL:SRN) today announced the launch in Japan of the world's smallest line of ICDs: OVATIO(TM).

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(TM) 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". He added: "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. This highly advanced device can prevent sudden cardiac arrest, the leading cause of death in Japan with an estimated 80,000 deaths each year.

The OVATIO(TM) ICD family includes innovative features dedicated both to pacing and arrhythmia management. Dual chamber OVATIO DR includes two exciting features: SafeR and PARAD+.

SafeR, Monitoring and Promoting the Patient's Natural Rhythm

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% of ICD patients with intrinsic conduction(i) compared to up to 50% for unselected conventional dual chamber patients. SafeR pacing technology has been available in Europe since September 2003.

PARAD+ (P And R Arrhythmia Detection), delivering therapies only when needed

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%(ii) to 69%(iii) inappropriate shocks, PARAD+ demonstrated a 99% overall specificity to these arrhythmias with out-of-the-box settings in a study recently published(iv), drastically reducing the number of inappropriate shocks.

"With the OVATIO(TM) 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.

About the Sorin Group:

The Sorin Group (Bloomberg: SRN.IM; Reuters: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney diseases. The Sorin Group includes these brands: Dideco, Carbomedics, COBE Cardiovascular, Stockert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Bellco-Soludia. It has more than 4,500 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers. For more information, please visit: www.sorin.com and www.sorin-crm.com.

(I )Internal data from Ovatio DR Clinical Release Report

(II )Prasad k. et al. Inappropriate Shocks in Patients Receiving Internal Cardioverter-Defibrillators for Maligant Ventricular Arrhythmias. Indian Heart Journal. July-Aug. 1997

(III) Korte T. et al. High Incidence of Appropriate and Inappropriate ICD Therapies in Children and Adolescents with Implantable Defibrillator. PACE July 2004

(IV) Hintringer F. et al. Comparison of the Specificity of Implantable Dual Chamber Defibrillator Detection Algorithms. PACE, 2004, vol.27: 976-982


Source: Sorin Group

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