Sorin Group’s Perceval (TM) Sutureless Aortic Valve Receives CE Mark Approval for Extended Age Indication

Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced today Perceval™, its sutureless aortic valve has received CE mark approval for adult age indication allowing treatment of a wider spectrum of patients with aortic stenosis and/or steno-insufficiency. Until now, only patients over 65 years of age could benefit from the Perceval technology.

Perceval is a bioprosthetic device designed to replace a diseased native or malfunctioning prosthetic aortic valve using either traditional or minimally invasive heart surgery. Implant with Perceval is easy⁽¹⁾ , safe^(1,2) and reproducible⁽³⁾ due to the unique technology that allows sutureless positioning and anchoring at the implantation site. This approval will give the opportunity to patients in the adult age with aortic stenosis or steno-insufficiency disease to be treated with this curative biological sutureless solution.

Clinical experience with this innovative device is growing rapidly. To date over 5,000 patients worldwide benefit from a Perceval sutureless aortic valve with 7 years of clinical experience.

The most recent clinical results were presented at the 50^th STS Annual Meeting in Orlando (Florida) by M. Shrestha, M.D., M.B.B.S., Ph.D., Hannover Medical School, Hannover (Germany), M. Glauber, M.D., G. Pasquinucci, Heart Hospital, Massa (Italy), C. Muneretto, M.D., Prof., University of Brescia Medical School, Brescia (Italy), and by F. Pollari, M.D., Klinikum Nuremberg, Nuremberg (Germany).

M. Shrestha received the ’best scientific poster’ award for adult cardiac surgery at the 50^th STS Annual Meeting 2014 for a study on the Perceval valve. This study on 243 patients⁽⁴⁾ confirmed Perceval’s excellent and stable hemodynamic performance, short operation time and very low complication and mortality rates, even in patients who underwent associated procedures, such as coronary artery bypass grafts, atrial fibrillation treatment and septal myectomy.

At the same congress, M. Glauber reported excellent results in 2 retrospective observational studies comparing Perceval with traditional valves and TAVI (Transcatheter Aortic Valve Implantation). Perceval actually performed better in terms of operating time reduction, intra-operative mortality and length of Intensive Care Unit (ICU) and hospital stay ⁽⁵⁾.

The retrospective study presented by F. Pollari also confirmed that Perceval had excellent clinical results and lower complication rate than with traditional biological valves and allowed important cost savings for the hospital, including shorter ICU and hospital stay⁽⁶⁾.

In addition to being the only sutureless valve reimbursed in Belgium, Perceval obtained incentive reimbursement for isolated aortic valve replacement over traditional biological valves from the German healthcare system earlier this year.

"We are consistently achieving key milestones with our breakthrough Perceval platform. With the recent approval of the Perceval XL model and now the adult age indication, we are now bringing Perceval clinical benefits to a larger number of patients,” said Michel Darnaud, President, Cardiac Surgery Business Unit, Sorin Group.

1) Santarpino et al. - Ann Thorac Surg 2013; 96(1) 77-81
2) Santarpino et al. - Ann Thorac Surg 2012; 94:504
3) Gilmanov et al., MMCTS (2013) 2013: mmt012 doi: 10.1093/mmcts/mmt012
4) Shrestha et al., STS 2014
5) Glauber et al., STS 2014
6) Pollari et al., STS 2014

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 3,750 employees worldwide, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery, heart valve prostheses and repair devices) 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 80 countries.

For more information, please visit www.sorin.com