Edwards grabs FDA green light for calcium-blocking, dry-storage TAVR heart implant

Edwards Lifesciences received FDA approval for the latest generation of its Sapien 3 transcatheter aortic valve, equipped with materials the company says will form the basis of its heart valve implants going forward.

The new version of the Sapien 3 Ultra is built with Edwards’ Resilia technology, which includes bovine pericardial tissue that has been treated to make the replacement valve more resistant to calcification, where mineral deposits can build up and become a major cause of implant failure.

Ten years in development, Resilia’s preservation treatment aims to extend the life span of a valve compared to traditional bioprosthetics while also allowing the implant to last longer in dry storage and offer simplified handling prior to a procedure.

“The Resilia tissue's anti-calcification technology addresses one of the primary causes of reintervention following heart valve replacement,” Larry Wood, Edwards’ corporate vice president for transcatheter aortic valve replacement, said in a release

The company said it plans to make the Sapien 3 Ultra Resilia valve available in the U.S. through a limited release in the fourth quarter. The Sapien 3 TAVR system is available in more than 75 countries and has also been approved for younger patients, who are considered to carry a low risk of complications from open-heart surgery.

Resilia is used in Edwards’ surgical Inspiris valve, which is placed through an open procedure. Though the company has not yet collected clinical data on the long-term impact of Resilia tissue itself, a clinical trial of the Inspiris valve showed sustained function and no structural deterioration over a period of five years.

The treated tissue will also be employed in the upcoming, next-generation Sapien X4 valve replacement, which is currently being tested in clinical studies of patients with severely calcified and narrowed aortic heart valves. Those trials are expected to run through at least 2025.

Meanwhile, last month, Edwards received a European approval for its Pascal Precision transcatheter valve repair system for treating mitral and tricuspid regurgitation. The minimally invasive system including its Pascal and Pascal Ace implants collected a CE mark for clasping together the leaflets of the heart valves to help them form a tighter seal.