Last week FDA approved Edwards Lifesciences Corp.’s Inspiris Resilia aortic valve, which the company is calling a new class of resilient heart valves. Intended for surgical aortic valve replacement, the device platform is built on the design of the Carpentier-Edwards Perimount valve, which has 20 years of clinical use behind it. The valve features tissue technology that combines anti-calcification properties, sustained hemodynamic performance and dry storage. Its VFit technology has an expandable frame and includes fluroscopically visible size markers and can be used in future valve-in-valve procedures.
The company plans to launch the valve in the United States early next year. It was launched in Europe earlier this year.