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Devices Cardiology FDA

 News Release - May 16, 2006

Sorin Group Announces FDA Approval of World's Smallest Implantable Cardioverter Defibrillator; OVATIO(TM) Offers Advanced Pacing and Defibrillation Technology to Patients at Risk for Sudden Cardiac Arrest

BOSTON, May 16 (Healthcare Sales & Marketing Network) - ELA Medical, part of Sorin Group (MIL:SRN), announced today at the Heart Rhythm Society's 27th Annual Scientific Sessions that it received approval from the U.S. Food and Drug Administration (FDA) to market OVATIO(TM), a new family of a dual and single chamber cardioverter defibrillators (ICDs).

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.

At only 29cc, OVATIO DR is the world's smallest dual-chamber (DR) ICD. For ICD patients having the smallest possible device implanted is important both for comfort and cosmetic reasons.

OVATIO DR also incorporates two exclusive features, AAIsafeR(TM) and PARAD(R)+, which will be discussed during a satellite breakfast symposium "New Approaches in Managing Complex ICD Patients" (May 18, 2006; 6:00 - 7:15 am; Westin Copley Place Hotel).

The AAIsafeR pacing mode limits unnecessary pacing in the right ventricle, which studies suggest may increase the risk of heart failure and atrial fibrillation(i, ii), both of which can prove fatal in addition to imposing a heavy cost burden on the healthcare system. Ventricular pacing was reduced to only 0.2 percent when AAIsafeR mode was used in OVATIO DR patients with intact conduction(iii).

Although ICDs save lives, they can, on occasion, deliver unnecessary shocks. OVATIO's PARAD/PARAD+ has been shown to be the industry best in reducing inappropriate shocks(iv).

"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. "OVATIO DR will set a high standard for ICD therapy and patient safety."

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.

Physiologically shaped, OVATIO also offers 34 joules of maximum output, which may prove useful for patients with high defibrillation thresholds that require more energy to terminate life-threatening arrhythmias.

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

"The introduction of the OVATIO family reflects Sorin Group's commitment to develop cutting-edge cardiac rhythm management systems," said Jim Pacek, President, ELA Medical Inc. "With this family of products, we demonstrate our commitment to the U.S. ICD market, which is estimated at over $5 billion in 2006."

ELA Medical:

ELA Medical, part of Sorin Group, designs and manufactures implantable pacemakers and ICDs, leads, and Holter equipment and markets them in Europe, the U.S. and Japan.

Sorin Group:

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.

REFERENCES

(i) Steinberg JS, Fischer A, Wang P, Schuger C, Daubert J, McNitt S, Andrews M, Brown M, Hall WJ, Zareba W, Moss AJ ; MADIT II investigators. The Clinical Implications of Cumulative Right Ventricular Pacing in the Multicenter Automatic Defibrillator Trial II. Journal of Cardiovasc Electr, April 2005 - Vol. 16 No. 4: 359-364.

(ii) Dual-Chamber Pacing or Ventricular Backup Pacing in Patients With an Implantable Defibrillator The Dual Chamber and VVI Implantable Defbrillator (DAVID) Trial. B L Wilkoff, MD, Chair; J R Cook, MD; A E Epstein, MD; H L Greene, MD; A P Hallstrom, PhD; H Hsia, MD; S P Kutalek, MD; A Sharma, MD. JAMA December 25, 2002 - Vol 288, No.24; 3115-3123

(iii) Internal clinical release report. Data on file.

(iv) Hintriger S et al; Comparison of the Specificity of Implantable dual chamber defibrillator detection algorithms. PACE 2004, Vol 27, pages 976-982


Source: Sorin Group

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