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Hospital Healthcare Europe

The Perceval S reaches another important milestone in its development process


6 October, 2010  

Sorin Group, a global medical company and a leader in the treatment of cardiovascular diseases, announced today the presentation by Francois Laborde, MD, Professor of Cardiac Surgery, Institut Mutualiste Montsouris, Paris, France at the 24th EACTS Annual Meeting in Geneva, Switzerland of the early clinical results of the first 180 patients implanted with the Perceval S Aortic Heart Valve (investigational device). The Perceval S sutureless biological valve represents the latest innovation in heart valve technology in a long line of innovative products designed and manufactured by Sorin Group.

The Perceval S is a self-anchoring surgical aortic valve with a unique self-anchoring frame thus enabling the surgeon to replace the diseased valve without suturing it into place. It comprises a functional component made of bovine pericardium fixed in a super-elastic alloy frame. This unique frame design is characterised by two ring segments specially designed elements to match the anatomy of the sinus and to allow the prosthesis anchoring to the aortic root. Perceval S provides minimal transvalvular gradient due to an optimal ratio between internal
and external device diameter. The system features a stentless aortic pericardial valve implanted in more than 10,000 patients with proven durability and optimal hemodynamics.

Between April 2007 and January 2010, 180 patients were enrolled in two consecutive clinical trials in 9 European centers aimed at demonstrating safety and effectiveness of the valve in high risk patients. Clinical
results indicated a significant reduction in surgical timings both for isolated and complex AVR.

The overall morbidity and mortality was low, and the hemodynamic performance was outstanding in particular in terms of pressure gradients and effective orifice area at 1 and 2 years.

”I am very pleased to be one of the principal investigators for the Perceval S heart valve. In my center we have successfully implanted 41 valves in this study, and I am so far very impressed by the ease of use and the performance of this valve”, said Prof. Francois Laborde,(Institut Mutualiste Montsouris, Paris, Fr). “Its innovative features bring an absolute stability once the valve has been correctly positioned. I believe this product will provide tremendous clinical benefits to patients. Its very short learning curve due to its user friendly features was appreciated by all members of my team and we look forward to its routine use”, added Prof. Laborde.

“We are proud to share this Perceval S Aortic Heart Valve experience of the first 180 patients with up to 3 years follow up. These results, of our latest curative, aortic heart valve device, enable greater clinical confidence and are a culmination of many years of research and development. This further underlines our commitment to deliver to cardiac surgeons high performance and innovative technology that advances the treatment of cardiovascular disease,” said Davide Bianchi, President Heart Valves Business Unit, Sorin Group.

Sorin Group is committed to advancing the treatment of cardiovascular disease through collaboration with leading clinicians worldwide.

Sorin