Edwards Lifesciences has announced the launch of the Sapien 3 Ultra Resilia valve—combining Edwards’ breakthrough Resilia tissue technology with the Sapien 3 Ultra transcatheter aortic valve implantation (TAVI) system. The launch follows recent US Food and Drug Administration (FDA) approval.
Resilia tissue is a bovine pericardial tissue treated with advanced anti-calcification technology and serves as the platform for Edwards’ new class of valves, including the next generation Sapien X4 valve, which is currently undergoing clinical trials.
Resilia tissue delivers important advances to the Sapien 3 Ultra platform including enhanced calcium blocking properties and dry tissue packaging conditions that facilitate ease of use, Edwards Lifesciences said in a press release. Resilia tissue has demonstrated freedom from structural valve deterioration at five years and provides the potential to extend the durability of the Sapien 3 Ultra Resilia valve. It is used in the Edwards’ surgical aortic valve, the Inspiris Resilia valve.
“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 US market today,” said Larry Wood, corporate vice president, transcatheter aortic valve replacement, Edwards Lifesciences. “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.”
The Sapien 3 Ultra Resilia valve will be available in the USA in limited release in the fourth quarter of 2022.