Sorin Group Announces the Completion of Patient Enrollment for the Perceval IDE Study in the USA

Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), 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. "The Perceval valve once approved in the US will complement Sorin’s already strong portfolio of pericardial aortic valve solutions, including the Solo Smart and Mitroflow PRT valves.”

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.

In a second study presented by Prof. M. Shrestha (European multi-center experience with sutureless Perceval valve: Clinical and haemodynamic outcomes up to 5 years in over 700 patients), Perceval demonstrated excellent and stable results at up to 5 years of follow-up. No valve migration, structural valve degeneration or valve thrombosis was observed in the largest patient cohort ever implanted with sutureless valves. Low early 30 day mortality (1.9%), low major early paravalvular leak (1.4%) and low early stroke (1.6%) suggested favorable safety and efficacy profile of the Perceval valve. An additional benefit was the very low endocarditis rate of 0.3%.

The EACTS 2014 Congress also highlighted the economic impact of Sorin’s innovative solutions with Prof. Bart Meuris, University Hospitals of Leuven, Belgium, who presented favorable health economic data for Perceval sutureless valves compared to traditional stented valves (Perimount valve from Edwards Lifescience). The mean total cost of the Perceval patients group compared with Perimount, net of valve costs, showed a reduction of 27 percent, i.e., a mean reduction of € 8,176 ($9,635) per case. These cost savings were mainly driven by reduced hospital stay costs and significantly lower procedural costs. In summary, patients implanted with Perceval recovered faster than with Perimount, which led to increased hospital savings overall.

In line with the European findings, a recently published article¹ reported the first successful experiences with Perceval in the US, highlighting how the absence of major surgical complications, identifiable reductions in bypass/cross-clamp times, and complete absence of paravalvular leak are potentially appealing features of this novel device for severe calcific aortic valve stenosis.

About Perceval
The Perceval™ sutureless biological valve represents one of the latest innovations in heart valve technology from a long line of innovative products designed and manufactured by Sorin Group. The surgical aortic value has a unique self-anchoring frame that enables the surgeon to replace the native diseased valve without suturing it into place. Perceval has now been implanted in over 8,000 patients in over 250 centers, in 44 countries in the world.

1. Hector I. Michelena et al, An Alternative for Surgical Management of Calcific Aortic Valve Stenosis: Sutureless Valve Implants, J Card Surg 2014;XX:1–4

About Sorin Group
Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With over 3,500 employees worldwide,Sorin Group focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement prostheses) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose arrhythmias and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment) Every year, over one million patients are treated with Sorin Group devices in more than 100 countries.

For more information, please visit www.sorin.com