Healthcare Industry News:  ExtraCorporeal Circulation 

Devices Cardiology FDA

 News Release - February 18, 2010

Sorin Group Announces U.S. FDA Clearance of Newest Generation Heart Lung-Machine

After a Successful European Launch in 2009, Sorin Group Receives U.S. Market Clearance for the C5 Heart-Lung Machine

MILAN, Feb 18--(HSMN NewsFeed)--Sorin Group, (MIL:SRN) a global company and a leader in the treatment of cardiovascular diseases, announced today the U.S. Food and Drug Administration (FDA) clearance of its newest generation C5 Heart-Lung Machine (HLM).

A Heart-Lung Machine is a sophisticated piece of medical equipment that provides blood oxygenation and circulation to organs and the brain while the patient's heart and lungs are temporarily stopped during a cardio-thoracic surgical procedure.

Sorin’s C5 HLM is the culmination of over 25 years of experience in extracorporeal perfusion system design and manufacturing.

The C5 HLM builds on the state-of-the-art technology and proven interface of Sorin’s S5 industry-standard HLM, while being lighter in weight and more compact. The C5 has excellent manoeuvrability and a well thought-out, logical structure, functional ergonomic design and reliable safety systems. Its solid, brushed stainless steel housing reflects the product´s high quality.

With the C5 HLM, Sorin obtained FDA clearance within one month of submission, the shortest clearance time for a heart lung machine on company record. The introduction of the C5 to the US market will further strengthen Sorin Group’s world leading position in the cardiopulmonary bypass market.

“The C5 HLM provides another example of Sorin Group’s commitment to developing solutions that meet the needs of both patients and clinicians. Our focus on delivering product and service excellence helps maintain our worldwide leading position”, said Michel Darnaud, President, Cardiopulmonary Business Unit and Intercontinental, Sorin Group.

The C5 HLM will be showcased for the first time in the USA at CREF – Cardiothoracic Surgery Symposium – in Newport Beach, CA on March 4-7, 2010.

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 3,500 employees worldwide, the Group focuses on three major therapeutic areas that include: cardiopulmonary bypass (ExtraCorporeal Circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over 1 million patients are treated with Sorin Group devices in more than 80 countries.

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Source: Sorin Group

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