Healthcare Industry News:  CarboMedics 

Devices Cardiology

 News Release - June 15, 2006

Sorin Group Announces First U.S. Implants of OVATIO DR Implantable Cardioverter Defibrillators

World's Smallest ICD Features New Technology that Prevents Unnecessary Right Ventricular Pacing

NICE, France & ARVADA, Colo.--(HSMN NewsFeed)--June 15, 2006--ELA Medical, part of Sorin Group (MIL:SRN), announced the first U.S. implants of its OVATIO(TM) implantable cardioverter defibrillator (ICD) family, which recently received U.S. Food and Drug Administration (FDA) clearance. These implants were conducted by Doctors Atul Prakash, Rodrigo Chan, and Louis Rechani on May 22, in New Jersey, Arizona, and Florida respectively. At 29cc, OVATIO is the world's smallest ICD. In addition, OVATIO dual-chamber model (DR) contains multiple unique features including; AAIsafeR mode, which prevents unnecessary right ventricular pacing, and PARAD+ , the second-generation of PARAD which is an industry-best algorithm for minimizing inappropriate shocks.

In conjunction with the first implants of OVATIO ICDs, ELA Medical is planning a nationwide awareness campaign for their innovative AAIsafeR technology that could spare ten thousands of patient hospitalizations for heart failure. The campaign is aimed at educating U.S. doctors on the patient risks involved in unnecessarily pacing the right ventricle in pacemaker and defibrillator recipients.

"OVATIO DR offers many unique features including small size, high output, high specificity of the PARAD+ feature, and the AAIsafeR algorithm. Many doctors may not be sufficiently aware of the fact that unnecessary ventricular pacing increases the risk of congestive heart failure and atrial fibrillation," said Dr. Atul Prakash, MD, Electrophysiologist and Director of Arrhythmia services, UMDNJ, Newark, NJ. "Both atrial fibrillation and heart failure affect patient mortality. Treatment of these conditions also imposes a heavy financial burden on the healthcare system. Limiting their incidence through the use of available technology should be a priority for both physicians and hospital administration."

Modern ICDs contain pacing functions that are designed to protect patients when the normal conduction system in the heart fails. Drugs that are used to control potentially lethal arrhythmias may also slow down the patient's normal heart rate or prevent conduction from the upper to the lower chambers of the heart.

Even ICD patients who rarely or never need ventricular pacing can expect to be paced a high percentage of the time with conventional pacing technology.

In response, ELA Medical developed a unique pacing mode for promoting the patient's natural electrical conduction from the atria to the ventricles. This mode, AAIsafeR, reduced ventricular pacing to only 0.2% in OVATIO DR patients with intact conduction.(1)

AAIsafeR is the innovative algorithm that reduces unnecessary right ventricular pacing and is the only mode that manages all three types of heart block (first, second and third degree).

PARAD+, another unique feature, enables OVATIO DR to discriminate Supraventricular tachycardia (SVT) from Ventricular Tachycardia (VT) down to heart rates of 100 bpm and treat any ventricular arrhythmias with anti-tachycardia pacing (ATP) in all zones, providing this as first-line therapy saves patients from unnecessary shocks that may traumatize them as well as reduce device longevity.

"Besides being the easiest and quickest ICD that I've ever implanted, I'm extremely excited about the full package that OVATIO DR offers" said Dr. Rodrigo Chan, MD, Electrophysiologist at Banner Baywood Heart Hospital in Arizona. "I like the small profile and the 34J of maximum output that provides an extra safety margin for patients with high defibrillation thresholds. That, coupled with AAIsafeR makes this an ideal device for my patients."

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.


(1). Sorin Group - ELA Medical, clinical study, data on file

Source: Sorin Group

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