The study demonstrated no incidences of structural valve deterioration at the five-year review mark
Edwards Lifesciences announced that its RESILIA tissue aortic valve has shown favourable safety and efficacy at five years in the COMMENCE clinical trial.
The trial showed that the company’s bioprosthetic surgical aortic valve with a novel RESILIA tissue platform demonstrated favourable safety and hemodynamic performance through a median of five years follow-up.
According to the company, the trial showed no incidences of structural valve deterioration (SVD) at the five-year review mark, which is seen as a major safety outcome.
Impacting the long-term durability of the valve, SVD may occur due to the formation of calcium on the valve’s tissue or by other damage.
Edwards has specifically formulated RESILIA tissue using an advanced integrity-preservation technology, which may avoid the cause of calcification leading to valve deterioration.
The technologies that are currently using the new tissue consist of the INSPIRIS RESILIA aortic valve and the KONECT RESILIA aortic valved conduit, which is said to be the first ready-to-implant solution for bio-Bentall procedures.
RESILIA tissue enables to store valve under dry packaging conditions
RESILIA tissue facilitates the storage of the valve under dry packaging conditions, in addition to its anti-calcification properties.
The prospective, non-randomised, multicentre, single-arm investigational device exemption (IDE) COMMENCE trial recruited 689 patients at 27 clinical sites across the US and Europe.
The trial assessed the safety and effectiveness of RESILIA tissue aortic valve in patients ages 18 and older with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery.
Edwards has now gathered data for a total of five years and it will continue to evaluate a subset of these patients through 10 years. The trial has recorded data equivalent to 2,989 patient-years of follow-up at this stage, said the company.
Edwards’ surgical structural heart corporate vice president Daveen Chopra said: “Beyond the COMMENCE study, Edwards continues to invest in research to examine different outcome measures to further validate the long-term performance and durability of RESILIA tissue.
“Evidence from the COMMENCE trial adds to the growing body of research that demonstrates the value of innovative, RESILIA tissue-based technologies in transforming care for patients, especially more active patients.”
Additional RESILIA tissue studies consist of a European feasibility study that assessed SVD in a cohort of 133 patients and an ongoing RESILIENCE clinical trial evaluating calcium deposits as a way to potentially predict long-term bioprosthetic valve durability.
In December 2020, Edwards Lifesciences treated first patient in the US clinical study of the minimally invasive device for mitral valve disease.