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.