U.S. Next? Sorin Gains Health Canada Approval for Perceval Valve

Italian cardio device company, Sorin Group, will soon be seeing its Perceval sutureless aortic valve on the market in Canada, having just gained approval.


We’ve covered Sorin’s Perceval valve extensively on our pages (see here). Fundamentally, while traditional valves require from 15 to 18 permanent sutures, 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 supportable claims of fewer complications. Additionally, the absence of a suturing ring maximizes the effective orifice area, providing excellent hemodynamics with stable results over time.

To date, the Perceval valve has been implanted in more than 12,000 patients in over 300 centers, in 34 countries across the world. It remains under review by the U.S. FDA.

Company comments

“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.”

Physician comments

“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.”

Source: Business Wire

Share your thoughts

Your email address will not be published. Required fields are marked *