Dive Brief:
- Edwards Lifesciences said it has secured FDA approval for the first surgical valve replacement designed for patients with tricuspid valve disease.
- The approval introduces a surgical option for a long-underserved area of structural heart care, extending Edwards’ Resilia tissue technology to the tricuspid position, a spokesperson told MedTech Dive in an email.
- Called Triformis Resilia, the valve has a flattened sewing ring shape that mirrors the native tricuspid valve’s annulus anatomy.
Dive Insight:
Surgery for isolated tricuspid regurgitation is rarely performed due to concerns about high mortality risk, Edwards said. In patients with the condition, the tricuspid valve allows blood to leak backward into the heart’s upper right chamber rather than flowing to the lungs.
However, a recent analysis of cardiac surgery outcomes in a Society of Thoracic Surgeons database suggests the risk is lower than previously observed. The model developed for the study predicted an operative mortality risk of 5.6%.
Edwards said its new valve approval is timely, with the analysis providing a benchmark for isolated tricuspid valve interventions.
The structural heart specialist also makes the Evoque transcatheter tricuspid valve replacement, a minimally invasive treatment for patients with severe tricuspid regurgitation. Evoque, which gained Food and Drug Administration approval in 2024, is the only FDA-authorized transcatheter replacement device for tricuspid regurgitation.
Edwards is awaiting the FDA’s nod for a label expansion for its Pascal transcatheter valve repair system in patients with tricuspid disease.
