Edwards Lifesciences (NYSE:EW) announced today that it launched its Sapien 3 Ultra Resilia transcatheter heart valve.
Irvine, California-based Edwards launched the valve following recent FDA approval. It incorporates the company’s Resilia tissue technology in the transcatheter aortic valve repair (TAVR) device.
Resilia, a bovine pericardial tissue treated with anti-calcification technology, serves as the platform for Edwards’ new class of valves. The company is using it while developing the next-generation Sapien X4 valve, which is currently undergoing clinical trials.
The tissue provides enhanced calcium blocking properties and dry tissue packaging conditions that facilitate ease of use, Edwards said. It demonstrated freedom from structural valve deterioration at 5 years. Edwards said it has the potential to extend the durability of the Sapien 3 valve.
Sapien 3 Ultra Resilia will be available in the U.S. through a limited release in the fourth quarter of 2022. The company said it factored the commercial opportunity related to approval into its 2022 financial outlook.
“The Sapien 3 Ultra Resilia valve builds on Edwards’ 40 years of leadership in tissue technology by combining advancements in tissue science with the industry-leading Sapien 3 Ultra valve to offer the only dry storage transcatheter heart valve on the U.S. market today,” said Larry Wood, corporate VP, transcatheter aortic valve replacement, Edwards. “The Resilia tissue’s anti-calcification technology addresses one of the primary causes of reintervention following heart valve replacement.
“The Sapien 3 Ultra Resilia valve is a prime example of Edwards’ continued focus on innovating to meet the current and future needs of patients to help them live longer, healthier and more productive lives.”