Edwards gets FDA nod for Triformis Resilia surgical tricuspid valve replacement

Edwards Lifesciences (NYSE:EW) said today that it received FDA approval for Triformis Resilia, its surgical tricuspid valve replacement.

Irvine, California–based Edwards says it represents a significant approval for the first surgical tricuspid valve designed specifically for patients with tricuspid valve disease. The company said at the end of 2025 that it earmarked the second half of 2026 for the launch of this valve system.

According to Edwards, approval introduces a purpose-built surgical option for a long-underserved area of structural heart care. It also brings the company’s Resilia technology to the tricuspid space.

Edwards designed its Resilia technology to extend valve durability. It utilizes bovine pericardial tissue treated with anti-calcification technology to serve as the platform for Edwards’ new class of valves. The calcium-blocking technology addresses structural valve deterioration, a primary cause of reintervention after valve replacement. Resilia features in valves like the Sapien M3 Ultra Resilia, Mitris Resilia mitral valve and more.

Triformis Resilia, meanwhile, is a stented trileaflet prosthetic heart valve comprised of the Resilia tissue. The company based the valve on its Perimount valve design with a nitinol wireform. Mounted on a retainer, it has a holder system attached to the valve. The holder has a dial turned prior to implantation, allowing the posts to fold inward during implantation.

Its unique sewing ring shape and profile are tailored to native tricuspid anatomy, the company says. Meanwhile, its features can ease orientation and implantation while avoiding suture looping.