ELA Medical Announces The European Launch of New Cardiac Resynchronization Therapy Defibrillator to Treat Heart Failure

MILAN , Italy , May 4/PRNewswire/ --

Drago Cerchiari, CEO of Sorin Group, announced that ELA Medical, a Sorin Group company, today launched in Europe the ALTO(r) 2 MSP 627 cardiac resynchronization therapy (CRT) defibrillator. This device complements ELA's CRT product line, offering physicians a complete range of products for the management of patients suffering from heart failure.

Heart failure, a condition characterized by the heart's inability to pump enough blood to meet the body's needs, is often accompanied by ventricular asynchrony due to abnormal activation of the two ventricles.

In addition, sudden cardiac death may occur in as many as 40 percent of all patients who suffer from heart failure(1).

Cardiac Resynchronization Therapy (also called biventricular pacing) seeks to restore cardiac coordination improving heart function and enhance patients' quality of life. Implantable Cardioverter Defibrillator (ICD) therapy with backup ventricular pacing increases survival in patients with life-threatening ventricular arrhythmias and prevents sudden cardiac death.

"ELA's pioneering involvement in cardiac resynchronization therapy dates back to the early 1990s with the first worldwide implant of a biventricular pacemaker. ELA also sponsored the first prospective randomized trial - the MUSTIC study - which assessed the efficacy of CRT in heart failure patients. The market introduction of ALTO(r) 2 MSP further reinforces ELA's continuing commitment to delivering optimal care to heart failure patients", said Bruno Inguaggiato, President ELA Medical.

The ALTO(r) 2 MSP system incorporates the latest therapies for heart failure patients and for sudden cardiac death prevention, including:

*     - ELA Medical's proprietary PARAD(r)/PARAD+ arrhythmia
*       discrimination that identifies and analyzes complex arrhythmias;
*     - fully configurable biventricular function with programmable
*       ventricle-to-ventricle delay and independent left ventricular output;
*     - rate-responsive biventricular and flexible pacing into
*       tachycardia detection zones;
*     - right ventricular sensing along with complete diagnostics and
*       advanced follow-up tools.

Small and long-lasting, the ALTO(r) 2 MSP system can be used in conjunction with a complete range of advanced left ventricular leads which can accommodate all venous anatomies.

The SITUS(r) OTW lead is a thin, flexible over-the-wire lead designed for ease of placement in small or tortuous veins particularly challenging to the physician implanting CRT devices. Its unique tip design allows it to be actively anchored into the lumen of a vein located on the left side of the heart and to reduce lead dislodgment. A silicone tip seal limits blood ingress into the lumen to allow easy guidewire re-insertion and maintain lead integrity.

The SITUS(r) LV lead is a stylet-driven lead with a distal, dual-curve design intended to provide lead stability and optimal left ventricular pacing. The SITUS(r) LV lead has gained wide acceptance with its ease of use, stability and unmatched performance.

ELA's SITUS(r) left ventricular ( LV ) and SITUS(r) over-the-wire (OTW) use the same guiding catheter. The guiding catheter of the SITUS(r) Left Ventricular Access System (LVAS) kit does not need to be split and can thus be removed simply at the end of the implant procedure.

"ALTO(r) 2 MSP is also available with ELA's TelassistanceTM function, which provides remote real-time viewing of the patient's data.

Using this easy-to-use secure link, physicians can participate in patient follow-up providing support in peripheral clinics where specialist knowledge may not be present. They also have the opportunity to consult and share experience with colleagues on difficult cases. A simple phone call opens access to the service", added Alain Ripart, Vice President ELA Medical.

ELA Medical, a Sorin Group Company (Reuters code: SORN.MI), designs and manufactures implantable pacemakers, ICDs, leads, Holter equipment and electrophysiology catheters for Europe , the U.S. and Japan .

(1) Uretsky B. F, Sheahan R.G. Primary Prevention of Sudden Cardiac Death in Heart Failure: Will the Solution Be Shocking? J Am Coll Cardiol. 1997; 30: 1589-97.

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

(5/5/04)