News | March 17, 2009

Enrollment Begins for Sorin Sutureless Aortic Valve in Europe

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

Related Content

ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study| June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Clinical Study| August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init