Healthcare Industry News:  cardiopulmonary 

Devices Cardiology Surgery Regulatory

 News Release - September 18, 2012

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

European CE Mark approval for extended indications of the PERCEVAL(TM) S Sutureless valve, expanding the market and paving the way for adoption of Minimally Invasive Cardiac Surgery

MILAN--(Healthcare Sales & Marketing Network)--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 2nd 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 2nd 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 (www.sorin.com) 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.

For more information, please visit www.sorin.com


Source: Sorin Group

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