Health Canada has granted approval to Sorin Group to market its Perceval sutureless aortic valve in the country.
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Perceval valve has a self-anchoring frame that enables the surgeon to replace the native diseased valve without sutures, unlike traditional valves that require between 15 and 18 permanent sutures.
The valve reduces surgical time and complexity, leading to shorter stays and fewer complications.
In addition, the absence of a suturing ring maximises the effective orifice area, providing improved haemodynamics with stable results over time.
Sorin Group Cardiac Surgery Business Unit president Michel Darnaud said: "Sorin is committed to innovation that improves patient outcomes, enhances surgical technique and delivers value for hospitals and the health system overall.
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"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."
Currently under review by US Food and Drug Administration, the valve has been implanted in more than 12,000 patients in more than 300 centres in 34 countries worldwide.
Germany Paracelsus Medical University Cardiovascular Center professor Theodor Fischlein said: "Perceval represents a major advance in surgical aortic valve technology because it reduces aortic cross-clamp times and provides outstanding haemodynamic performance.
"A broad range of patient types can benefit from a sutureless approach, including higher-risk patients and those undergoing a concomitant procedure."
Apart from securing Canadian approval, Sorin has also completed US enrolment 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.
The company also presented two major Perceval studies at the 95th Annual American Association of Thoracic Surgery Meeting, held in May at Baltimore Convention Center in Maryland, US.
Image: Perceval sutureless valve reduces surgical time by enabling the surgeon to replace the native diseased valve without sutures. Photo: courtesy of Business Wire.
