Edwards Lifesciences makes a simple change for a first-of-its-kind tricuspid valve
π₯ Edwards Lifesciences received FDA approval in May 2026 for the Triformis Resilia, the first surgical valve specifically designed and approved for the tricuspid position.
π§ The device features a critical design change: a flattened sewing ring along the septal region to match native tricuspid anatomy and avoid AV node disruption.
β οΈ Previously, surgeons used mitral valves for tricuspid replacements because no dedicated surgical tricuspid valves were approved due to market size and clinical study challenges.
𦴠The valve utilizes Edwards' Resilia tissue technology with three bovine pericardial leaflets attached to a lightweight nitinol wireform frame.
π Triformis is available in five sizes ranging from 25 mm to 33 mm to accommodate various patient anatomies.
𧬠The nitinol wireform allows the stent posts to fold 55° during implantation, which helps avoid suture looping and facilitates placement.
π‘οΈ A cobalt-chromium alloy band and a polyester band provide structural support for the valve's orifice below the wireform.
π Orientation markings on the sewing ring include black lines for commissures and letters 'A' and 'S' to identify anterior and septal segments.
π§ͺ The sewing ring is made of compliant silicone-rubber covered with porous PTFE cloth to facilitate tissue ingrowth and encapsulation.
π‘οΈ Edwards Integrity Preservation technology uses glycerol-based dry storage instead of glutaraldehyde to reduce calcification and eliminate residual aldehyde groups.
π Pre-clinical studies demonstrated no significant conduction abnormalities, optimal seating, and good hemodynamic performance with leaflet mobility.
π Edwards plans to launch the Triformis Resilia valve in the second half of 2026 to address this long-underserved area of structural heart care.
- Edwards Lifesciences received FDA approval in May 2026 for the Triformis Resilia, becoming the first surgical valve specifically designed and approved for the tricuspid position.
- The new valve introduces a purpose-built option for a long-underserved area of structural heart care, addressing an unmet patient need where surgeons previously had to use mitral valves for tricuspid replacements.
- Pre-clinical studies demonstrated no significant conduction abnormalities and optimal seating, effectively avoiding AV node disruption which can cause abnormal heart rhythms.
- The valve features Edwards Integrity Preservation technology that reduces calcification and pannus while enhancing durability and hemodynamic performance through dry storage methods.
- Edwards plans to launch the Triformis Resilia valve in the second half of 2026, expanding its Resilia tissue technology portfolio to the tricuspid position.
- The article notes that manufacturers have not innovated on dedicated surgical tricuspid valves due to a 'relatively small market' and 'challenges in conducting prospective clinical studies', which may limit the potential revenue upside for this new product.
- Edwards Lifesciences states that surgeons previously had to use mitral valves for tricuspid replacements because there were no approved dedicated options, indicating a historical lack of innovation in this specific anatomical area.