September 28, 2022

Edwards updates the Sapien TAVR device for greater durability

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Diving 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 allows for dry storage and could extend the durability of the device.
  • Edwards factored the product, which recently gained Food and Drug Administration approval, into its 2022 financial expectations. provide transcatheter aortic valve replacement (TAVR) sales of $3.5 billion to $3.7 billion.

Overview of the dive:

Edwards’ Resilia technology is designed to address structural deterioration of the valve. While the studies to have found the rate of deterioration with the 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 approximately 15 years. As TAVR expands to younger patients, devices will need to last longer.

Because calcium buildup is a spoilage factor, Edwards treated bovine pericardial tissue with anti-calcification technology to create Resilia. In a preclinical study in a juvenile sheep model, researchers have seen 72% less calcium after eight months in treated valves compared to controls.

Edwards has applied the technology to several products, with Edwards CEO Mike Mussallem pointing to the “high adoption” of the Mitris Resilia valve, which was launched in the United States in April, on a recent conference call with investors. Applying 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 US market today,” adding that it “addresses one of the main causes of reoperation”. following heart valve replacement.

Edwards’ experimental Sapien X4 valve also uses Resilia technology. The company is running a pivotal trial of the new device.