Health Canada approves Sorin’s Perceval sutureless aortic valve

Aug 7 2015

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

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.

Perceval Sutureless Valve (Photo: Business Wire).

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. Additionally, the absence of a suturing ring maximizes the effective orifice area, providing excellent hemodynamics with stable results over time.

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.