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Sorin Group Gets US FDA Clearance For C5 Heart-Lung Machine

Sorin Group has received FDA clearance for its new C5 Heart-Lung Machine (HLM), which 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 builds on the technology and interface of its S5 industry standard HLM, while being lighter in weight and more compact. The C5 has manoeuvrability and a logical structure, functional ergonomic design and reliable safety systems. Sorin said that C5 HLM is the result of its expertise in extracorporeal perfusion system design and manufacturing.

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

Michel Darnaud, president of cardiopulmonary business unit and intercontinental at Sorin Group, said: “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.”

Sorin develops, manufactures and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. 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.