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.
“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”, commented 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. Buillding on the Pericarbon Freedom™ Valve, a well-established Sorin Group pericardial stentless valve in the European market since 1991, the Perceval valve features a unique stent design.
“This breakthrough prosthesis is designed to be implanted using a quick metal stent deployment technique thus obviating the need for using time-consuming, conventional suturing techniques. The success behind Sorin’s heart valve lies in the Group’s in-house competencies in stent research and development as well as its historic prominence in heart-valve development and production. We are confident that Perceval S Sutureless Aortic Heart Valve will set a new standard in the Aortic Valve Replacement,” said André-Michel Ballester, CEO, Sorin Group.
Source: Sorin Group