Medical device firm Sorin Group has received approval from Health Canada for its new Perceval sutureless aortic valve.
Perceval valve features self-anchoring frame that allows the surgeon to replace the native diseased valve without sutures, while traditional valves need 15 to 18 permanent sutures.
The absence of a suturing ring is said to maximize the effective orifice area, offering enhanced hemodynamics with stable results over time.
Sorin Group cardiac surgery business unit president Michel Darnaud said: "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."
Currently, the Perceval valve is being reviewed by the US Food and Drug Administration and it was implanted in around 12,000 patients at 300 centers in 34 countries, according to Sorin.
The company presented two major Perceval studies at the 95th Annual American Association of Thoracic Surgery Meeting.
At the event, the company also announced the completion of US 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.
Image: Sorin’s Perceval sutureless valve. Photo: courtesy of Business Wire.