Healthcare Industry News:  OVATIO CRT 

Devices Cardiology

 News Release - June 19, 2006

Sorin Group Initiates Multi-Center 'BITAC' Study in Europe

First Patient Enrolled in the Study Was Implanted with OVATIO CRT, The World's Smallest CRT D Device

PARIS--(HSMN NewsFeed)--June 19, 2006--Sorin Group (MIL:SRN) Cardiac Rhythm Management (CRM) Business Unit, an innovative leader in the hemodynamic management of heart failure, announces today first patient enrollment in the BITAC (BIventricular TAchycardias Outcome in CRT-D Patients) clinical study.

The purpose of the BITAC study is to assess the incidence of slow ventricular tachycardias (VTs) in heart failure patients implanted with CRT-D devices, as well as the clinical relevance of treating slow VTs during a 2-year follow-up period. The principal investigator for the study is Dr. Alexander Bauer, University Hospital of Heidelberg.

Sub-analysis of studies performed in a general implantable cardioverter defibrillator (ICD) population has shown that slow VTs (lower than 150 beats per minute) are more prevalent and have more serious consequences in those patients with depressed ventricular function(1). The BITAC study specifically aims to address the clinical relevance of slow VTs in a heart failure population and to offer physicians better insight on how to improve the management of ventricular arrhythmias in CRT-D patients.

Patients included in the multicenter BITAC study have advanced heart failure and are at increased risk of sudden cardiac death (SCD), a condition in which the heart stops suddenly and unexpectedly.

Heart failure, an inability of the heart to pump enough blood to meet the body's needs, affects 10 million Europeans(2). Cardiac resynchronization therapy (CRT) devices deliver pacing impulses to the heart muscle to resynchronize the contractions of the ventricles and thus increase cardiac pump efficiency.

As heart failure patients are up to 9 times more likely to suffer SCD than the general population(3), combining CRT with an implantable defibrillator (CRT-D) can be life-saving for these patients.

The first patients to be enrolled in the study were implanted with Sorin Group's Ovatio(TM) CRT, the world's smallest CRT-D. The device includes the unique Brady Tachy Overlap (BTO(TM)) function which allows the setting of low-rate detection zones for slow VTs, whilst still allowing pacing and delivery of resynchronization therapy during patient exercise.

The implants were performed at the St. Adolf-Stift Hospital in Reinbek, Germany by Dr. Herbert Nagele, Senior Assistant Medical Director, and at the Hospital Fernando Da Fonseca in Amadora, Portugal by Dr. Francisco Madeira, Assistant Cardiologist and Electrophysiologist, and by Dr. Pedro Cunha, Assistant Cardiologist, in the Pacing and Arrhythmia Unit headed by Dr. Carlos Morais.

Dr. Francisco Madeira commented: "this important study will give physicians better insight into the management of slow VTs for heart failure patients. It will be of particular interest because, until today, technology limitations restricted our ability to monitor and treat slow VTs in HF patients without compromising the delivery of cardiac resynchronization therapy ".

Andre-Michel Ballester, President of Sorin Group Cardiac Rhythm Management (CRM) Business Unit commented that "this study represents a continuation of Sorin Group's efforts to bringing innovative technology to each and every patient. Our objective is to demonstrate the ability of Sorin's unique BTO function to monitor the effects of slow VT for heart failure patients".

The BITAC study will enroll over 400 patients across Europe. Enrollment is anticipated to be completed by end 2007.

Sorin Group:

Sorin Group CRM Business Unit designs and manufactures implantable pacemakers and ICDs, leads and Holter equipment and markets them worldwide.

Sorin Group (Reuters code: 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. Sorin Group includes: Dideco, CarboMedics, COBE Cardiovascular, Stockert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. Sorin Group has more than 4,700 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.

For additional information, please visit our website: www.sorin.com

REFERENCES

(1). Sadoul N., Mletzko R., Anselme F. et al. Internal sub analysis (375 patients) of the IDEF08 Slow VT study. Incidence and Clinical Relevance of Slow Ventricular Tachycardia in Implantable Cardioverter-Defibrillator Recipients: An International Multicenter Prospective Study. Circulation Aug16,2005, 946-953

(2). Cleland JG, Swedberg K, Follath F et al.The EuroHeart Failure Survey Programme- A Survey of the Quality of Care Among Patients with Heart Failure in Europe. Part 1: Patient Characteristics and Diagnosis. Eur Heart J 2003;24:442-463

(3). American Heart Association.Heart Disease and Stroke Statistics. 2005 Update. Dallas, Texas: American Heart Association


Source: Sorin Group

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