Sorin Group, a global medical device company and leader in cardiovascular diseases, announced completion of US enrollment of the Perceval Investigation Device Exemption (IDE) Trial.
The trial enrollment was completed on schedule with the implantation of 300 patients.
The IDE study is designed as a prospective, non-randomized, multi-center clinical trial. The purpose of this study is to demonstrate the safety and effectiveness of the Perceval valve when used to replace diseased or dysfunctional aortic valves or aortic valve prostheses.
The patients enrolled in the US IDE study were all adult patients suffering from aortic valve stenosis or steno-insufficiency, indicated for native or prosthetic aortic valve replacement and available for postoperative follow-up beyond one year.
In total, eighteen (18) centers across the US took part in the study with the first patient enrolled in June 2013. The US principal investigator of the study is Rakesh Suri, M.D., Ph.D., Mayo Clinic. The objectives of the trial are to establish safety and clinical efficacy of the Perceval valve in comparison to historical controls.
"We are very excited to have completed this important milestone which wouldn’t have been possible without the outstanding involvement of this study’s investigators under the leadership of Dr Suri. We now very much look forward to the results," said Michel Darnaud, Sorin Group, President, Cardiac Surgery Business Unit.
For the patients who remain candidates for traditional surgical aortic valve replacement, the Perceval valve offers the potential benefit of shortening the time spent supported by the heart-lung machine. All this is performed without the need for sutures around the valve, thereby offering the possibility of shorter operative times, decreased complication rates, and use of minimally invasive approaches.
Results from a similar study conducted in Europe were presented at the recent EACTS congress in Milan. The Perceval CAVALIER Trial included results from a pooled European multi-center experience.
The trial was designed to evaluate the safety and effectiveness of the Perceval valve in a large population requiring aortic valve replacement (AVR) with or without concomitant coronary bypass grafting.
A total of 658 patients were implanted at 25 European centers. The 30-day results, presented by Prof. F. Laborde, IMM, Paris, France, demonstrated the safety of Perceval with excellent hemodynamics, a low complication rate, and ease of implant with a reproducible technique in both traditional sternotomy and the less invasive approach.