March 17, 2009 – Sorin Group recently announced the enrollment of the first three patients in a clinical trial aimed at obtaining European market approval for its Perceval S Sutureless Aortic Heart Valve.
In a previous first-in-man pilot study, 30 patients at high surgical risk were enrolled in three European centers. The new Perceval S clinical trial will involve some 150 patients at high surgical risk in nine centers throughout Europe.
The first three implants of the clinical trial were performed at the Institut Mutualiste Montsouris (IMM) in Paris.
“We successfully implanted the first three patients in this important trial. I was able to appreciate the innovative characteristics of the device in terms of safety, procedural success and clinical outcome,” said Professor François Laborde, chief of cardiac surgery at the IMM hospital. “This valve allows the removal of the diseased valve, precise positioning and fast release and implantation, and therefore, ultimately a significant reduction of surgical time,” he added.
The Sorin Group Perceval S Sutureless Aortic Heart Valve is a bioprosthesis made of a bovine pericardial tissue assembled on a super-elastic metal alloy stent. Building on the Pericarbon Freedom Valve, a Sorin Group pericardial stentless valve on the European market since 1991, the Perceval valve features a unique stent design.
The design allows implantion using a quick metal stent deployment technique to avoid using time-consuming, conventional suturing techniques.
The company says key benefits of the Perceval S valve include reduced implantation time, use of a well-established bovine pericardial valve, super-elastic metal alloy stent, optimal aortic wall anchoring and sealing, and a detoxification treatment.
For more information: www.sorin.com