Edwards Sapien 3 Ultra Resilia Valve Approved and Launched in United States

September 12, 2022—Edwards Lifesciences announced the FDA approval and commercial launch of the Sapien 3 Ultra Resilia valve. The Sapien 3 Ultra Resilia valve will be available in the United States in limited release in the fourth quarter of 2022.

The device incorporates Edwards’ Resilia tissue technology with the Sapien 3 Ultra transcatheter aortic heart valve. Resilia serves as the platform for Edwards’ new class of valves, including the next-generation Sapien X4 valve, which is currently undergoing clinical trials, noted the company.

According to Edwards, Resilia is a bovine pericardial tissue treated with anticalcification technology. Resilia tissue provides the Sapien 3 Ultra platform with enhanced calcium-blocking properties and dry tissue packaging conditions that facilitate ease of use.

The Resilia technology has demonstrated freedom from structural valve deterioration at 5 years and offers the potential to extend the durability of the Sapien 3 Ultra Resilia valve. It is used in Edwards’ Inspiris Resilia surgical aortic valve, stated the company.