FDA approve “first-in-class” resilient surgical valve

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Inspiris Resilia

Edwards Lifesciences has FDA approval for its Inspiris Resilia surgical aortic valve, which a press release reports is the first in a new class of resilient heart valves. The press release adds that the valve features Resilia tissue, which is designed to deliver the combination of enhanced anticalcification properties, improved sustained haemodynamic performance and dry storage.

The valve also has “first-of-its-kind” expandable frame—VFit technology—that incorporates fluoroscopically visible size markers and is designed for potential future valve-in-valve procedures. Also, its valve platform is built on the performance of the Carpentier-Edwards Perimount valve.

Approval of the Inspiris valve is supported by the COMMENCE pivotal trial. Published in the European Journal of Cardio-Thoracic Surgery, two-year data of 689 patients from the COMMENCE trial showed no cases of structural valve deterioration, valve thrombosis or non-structural valve dysfunction. Additionally, the European Resilia tissue feasibility study, which initiated enrolment in 2011, underscores the safety and effectiveness of the tissue. Four-year results from the European feasibility study will be presented at the 31st European Association for Cardio-Thoracic Surgery’s (EACTS) annual meeting (7–October, Vienna, Austria).

John D Puskas (Icahn School of Medicine, New York, USA), comments: “The Inspiris valve sets a new benchmark for surgical aortic valve replacement, providing patients, particularly those with active lifestyles, with a resilient tissue valve that is built on Edwards’ legacy of excellence in heart valve innovations.”

The press release states that plans are underway for a full US launch of the Inspiris valve in early 2018. The valve became commercially available in Europe earlier this year.

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