Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the enrolment 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 pilot study (First-In-Man), 30 patients at high surgical risk were enrolled in three European centres. The new Perceval S clinical trial will involve some 150 patients at high surgical risk in 9 centres throughout Europe.
The first three implants of the clinical trial were performed at the Institut Mutualiste Montsouris (IMM) in Paris.
Professor François Laborde, Chief of Cardiac Surgery at the IMM hospital, 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. 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.