Sorin Group S.p.A. Obtains Health Canada Approval for Perceval, Its Next Generation Sutureless Valve

First sutureless tissue valve that reduces surgical time is now available in North America

MILAN--(BUSINESS WIRE)--Sorin Group, (Reuters Code: SORN.MI) (MIL:SRN), a global medical device company and a leader in the treatment of cardiovascular diseases, today announced the Canadian approval of its Perceval sutureless aortic valve.

“Sorin is committed to innovation that improves patient outcomes, enhances surgical technique and delivers value for hospitals and the health system overall”

Traditional valves require from 15 to 18 permanent sutures, but the Perceval valve is designed with a unique self-anchoring frame that enables the surgeon to replace the native diseased valve without sutures. This innovation reduces procedure time and complexity, leading to shorter stays and fewer complications.^1,2,3 Additionally, the absence of a suturing ring maximizes the effective orifice area, providing excellent hemodynamics with stable results over time.^4,5

The Perceval valve is currently under review by the U.S. Food and Drug Administration. To date, it has been implanted in more than 12,000 patients in over 300 centers, in 34 countries across the world.

“Sorin is committed to innovation that improves patient outcomes, enhances surgical technique and delivers value for hospitals and the health system overall,” said Michel Darnaud, President Cardiac Surgery Business Unit, Sorin Group. “We believe Perceval meets each of these criteria and has the potential to become the standard of care for patients who require surgical valve replacement procedures. We look forward to working with the surgical community in Canada to bring this important new option to patients.”

“Perceval represents a major advance in surgical aortic valve technology because it reduces aortic cross-clamp times and provides outstanding hemodynamic performance,” said Prof. Theodor J.M. Fischlein, M.D., Ph.D., Paracelsus Medical University Cardiovascular Center, Nuremberg, Germany. “A broad range of patient types can benefit from a sutureless approach, including higher-risk patients and those undergoing a concomitant procedure.”

The Canadian approval of Perceval is the latest in a series of milestones for Sorin Group in North America, including the presentation of two major Perceval studies at the 95th Annual American Association of Thoracic Surgery Meeting, the completion of U.S. enrollment for the Perceval Investigation Device Exemption (IDE) Trial and the introduction of both the Memo 3D™ ReChord for mitral valve repair and Solo Smart stentless bioprosthesis.

To learn more about Sorin’s innovative portfolio of surgical valve solutions, visit www.sorin.com.

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 3,900 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

References :

1. Santarpino G, Pfeiffer S, Concistrè G et al. The Perceval S aortic valve has the potential of shortening surgical time: does it also result in improved outcome? Ann Thorac Surg. 2013;96:77-81.
2. Santarpino G, Pfeiffer S, Schmidt J et al. Sutureless aortic valve replacement: first-year single-center experience. Ann Thorac Surg. 2012;94:504-8.
3. Pollari F, Santarpino G, Dell’Aquila AM et al. Better short-term outcome by using sutureless valves: a propensity-matched score analysis. Ann Thorac Surg. 2014;98:611-6.
4. Shrestha M, Fischlein T, Meuris B, Flameng W, Carrel T, Madonna F, Misfeld M, Folliguet T, Haverich A, Laborde F. European multicentre experience with the sutureless Perceval valve: clinical and haemodynamic outcomes up to 5 years in over 700 patients - Eur J Cardiothorac Surg. 2015 Mar 6.
5. Folliguet TA, Laborde F, Zannis K et al. Sutureless perceval aortic valve replacement: results of two European centers. Ann Thorac Surg. 2012;93:1483-8.