Dive Brief:
- Edwards Lifesciences is planning a limited U.S. release of its Sapien 3 Ultra Resilia transcatheter aortic heart valve in the fourth quarter.
- The device combines Edwards’ existing Sapien 3 Ultra transcatheter aortic heart valve with its Resilia tissue technology, resulting in a product that the company says enables dry storage and could extend device durability.
- Edwards has factored the product, which recently won Food and Drug Administration approval, into its financial expectations for 2022. The company forecast transcatheter aortic valve replacement (TAVR) sales of $3.5 billion to $3.7 billion.
Dive Insight:
Edwards’ Resilia technology is designed to address structural valve deterioration. While studies have found the rate of deterioration with TAVR is lower than with the older surgical aortic valve replacement, some devices still develop problems within the first five years. The average lifespan of a bioprosthetic valve is around 15 years. As TAVR moves into younger patients, devices will need to last longer.
Because calcium buildup is a driver of deterioration, Edwards has treated bovine pericardial tissue with anti-calcification technology to create Resilia. In a preclinical juvenile sheep model study, researchers saw 72% less calcium content after eight months in the treated valves compared to the controls.
Edwards has applied the technology to multiple products, with Edwards CEO Mike Mussallem highlighting the “strong adoption” of the Mitris Resilia valve, which launched in the U.S. in April, on a recent conference call with investors. The application of the technology to Sapien gives Edwards new features to push as it competes with Medtronic for the TAVR market.
In a statement, Larry Wood, vice president of transcatheter aortic valve replacement at Edwards, said Sapien 3 Ultra Resilia is “the only dry storage transcatheter heart valve on the U.S. market today,” adding that it “addresses one of the primary causes of reintervention following heart valve replacement.”
Edwards’ investigational Sapien X4 valve also uses Resilia technology. The company is running a pivotal trial of the new device.
