Sorin Group has obtained an extended CE Mark approval for its sutureless aortic valve Perceval to include patients with aortic stenosis or steno-insufficiency who are younger than 65 years old.
Until now, only patients older than 65 years of age could benefit from the Perceval technology.
Perceval is a bioprosthetic device designed to replace a diseased native or malfunctioning prosthetic aortic valve using either traditional or minimally invasive heart surgery.
With its anchoring frame, the surgical aortic valve enables the surgeon to replace the diseased valve without suturing it into place.
One of the most common valvular heart abnormalities, aortic stenosis is a degenerative disease resulting from a progressive age-dependent build-up of calcium that disrupts blood flow across the aortic valve.
The company said that clinical experience with this innovative device is growing rapidly and Perceval has been successfully used in more than 5,000 patients globally to date.
According to the company, clinical results from a 243-patient study, presented recently at the Society of Thoracic Surgeons (STS) annual meeting confirmed Perceval’s stable haemodynamic performance, short operation time and very low complication and mortality rates, even in patients who underwent associated procedures.
The retrospective study presented at the same congress also confirmed that Perceval had excellent clinical results and lower complication rates than with traditional biological valves. It also allows important cost savings for the hospital, including shorter ICU and hospital stays.
Earlier this year, Perceval obtained incentive reimbursement for isolated aortic valve replacement over traditional biological valves from the German healthcare system. It is also the only sutureless valve reimbursed in Belgium.
Sorin Group cardiac surgery business unit president Michel Darnaud said: "With the recent approval of the Perceval XL model and now the adult age indication, we are now bringing Perceval clinical benefits to a larger number of patients."
According to GlobalData estimates, the tissue aortic valve replacements market in Europe was valued at $301m in 2012 and is expected to grow at a CAGR of 5.5% to reach $436.7m by 2019.