Sorin Group Announces CE Mark Approval of Extended Indications and 2nd Generation Accessories for Perceval S

Tue, 09/18/2012 - 8:20am
The Associated Press

MILAN--(BUSINESS WIRE)--Sep 18, 2012--Sorin Group, (Reuters Code: SORN.MI)(MIL:SNR), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today it has received CE Mark approval for extended indications of PERCEVAL TM S, as well as for an entirely re-designed 2 nd generation set of implantation accessories. PERCEVAL TM S is a bioprosthetic valve designed to replace a diseased native or malfunctioning prosthetic aortic valve via open heart surgery with the unique characteristic of allowing sutureless positioning and anchoring at the implantation site.

The implantation of PERCEVAL TM S was previously limited to patients 75 years of age or older. With extended indications, the use of PERCEVAL TM S is now approved for use in patients 65 years of age or older with aortic valve stenosis or steno-insufficiency. Aortic stenosis, one of the most common valvular heart abnormalities, is a degenerative disease resulting from a progressive age-dependent build-up of calcium that disrupts blood flow across the aortic valve.

The 2 nd generation implantation accessories for PERCEVAL TM S were designed to provide enhanced ease of use and ergonomics, as well as specific implantation accessories for the Minimally Invasive Cardiac Surgery (MICS) implantation of PERCEVAL TM S either through a partial sternotomy or right mini-thoracotomy. MICS techniques are increasingly important for Aortic Valve Replacement (AVR) because they reduce surgical trauma and morbidity which is an important consideration for the growing number of AVR patients.

“After its initial European market clearance in 2011, PERCEVAL TM S, a unique sutureless aortic valve, has proven to be a revolution in cardiac surgery, optimizing both operating time and clinical outcomes,” said Davide Bianchi, Sorin Group, President, Heart Valves Business Unit. “We are excited to provide this innovative treatment to a wider patient population, and to support the cardiac surgeon community to perform more and more Minimally Invasive Cardiac Surgeries.” About Sorin Group Sorin Group ( ) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,750 employees worldwide, Sorin Group focuses on three major therapeutic areas: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management and heart valve repair and replacement. Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.

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CONTACT: Martine Konorski Director, Corporate Communications Sorin Group Tel: +33 (0)1 46 01 33 78 Mobile: +33 (0)6 76 12 67 73 or Francesca Rambaudi Director, Investor Relations Sorin Group Tel: +39 02 69969716 KEYWORD: EUROPE ITALY INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CARDIOLOGY MEDICAL DEVICES SOURCE: SORIN GROUP Copyright Business Wire 2012 PUB: 09/18/2012 08:20 AM/DISC: 09/18/2012 08:20 AM


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