Sorin Group Completes Enrollment of Perceval Valve IDE Trial

Cardiovascular devicemaker Sorin Group has completed U.S. enrollment of its Perceval valve clinical trial. The device, used to replace diseased of dysfunctional aortic valves or aortic valve prostheses, has been implanted in 300 patients across 18 centers, Sorin said Monday.

The trial is evaluating the safety and effectiveness of the valve in adults suffering from aortic valve stenosis or steno-insufficiency. The first patient enrolled in June 2013.

The Perceval valve offers traditional surgical aortic valve candidates a shorter time spent supported by a heart-lung machine, the Italian devicemaker said. The implant procedure is performed without sutures around the valve, which reduces operation time and the likelihood of complications.

In a similar European trial of 658 patients at 25 centers, use of the Perceval valve was associated with excellent hemodynamics, low complication rates and easy implantation when traditional sternotomy and less-invasive approaches were used, the devicemaker said. — Kellen Owings