Edwards Lifesciences has received CE mark approval for its Inspiris Resilia aortic valve to treat heart valve patients.
The new valve integrates Resilia tissue, which uses the firm’s integrity preservation technology that preserves the tissue and offers improved anti-calcification properties and sustained hemodynamic performance.
Inspiris valve also features VFit technology, which is designed for potential future valve-in-valve procedures
The approval was based on Commence pivotal trial, which is a global and the US Food and Drug Administration premarket approval study.
According to the company, the results of 673 patients showed no cases of structural valve deterioration, valve thrombosis or nonstructural valve dysfunction.
The company is planning a targeted commercial release of the system in the fourth quarter of this year, while the full launch in the first quarter of next year.
Edwards surgical heart valve therapy corporate vice president Bernard Zovighian said: "The INSPIRIS valve creates a new class of surgical valves and includes key patient-focused innovations, such as the resilient tissue and the VFit technology, to advance the treatment of patients with heart valve disease.
“In partnership with surgeons, Edwards is committed to developing differentiating technologies that set a new standard for surgical heart valves."
In August, the firm received an expanded approval from the US Food and Drug Administration (FDA) for its Sapien 3 transcatheter heart valve to treat patients suffering from severe and symptomatic aortic stenosis.
Sapien 3 is claimed to be the first transcatheter aortic valve replacement (TAVR) therapy approved to treat patients suffering from severe and symptomatic aortic stenosis who have been determined by a heart team to be at intermediate risk for open-heart surgery.
Image: Edwards Lifesciences’ Inspiris Resilia aortic valve. Photo: courtesy of Edwards Lifesciences Corporation.