News | Heart Valve Technology | September 21, 2017

Edwards Inspiris Resilia Valve Receives FDA Approval

Surgical aortic valve device features expandable frame with enhanced tissue technology

Edwards Inspiris Resilia Valve Receives FDA Approval

September 21, 2017 — Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia aortic valve, the first in a new class of resilient heart valves.

"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," said John D. Puskas, M.D., MSc, FACC, FACS, professor of cardiothoracic surgery, Icahn School of Medicine at Mount Sinai, chairman, Department of Cardiothoracic Surgery, Mount Sinai Saint Luke's, Mount Sinai Beth Israel and Mount Sinai West (Roosevelt) and national principal investigator of the COMMENCE pivotal trial, an FDA premarket approval study.

Joseph Bavaria, M.D., Roberts-Measey professor and vice chief of cardiovascular surgery at the University of Pennsylvania and the top implanter in the COMMENCE pivotal trial, said, "With the addition of VFit technology, featuring the unique expandable design feature, the Inspiris valve provides an ideal foundation for heart valve patients, both now and in the future."

The INSPIRIS valve features three differentiating elements:

  • Resilia tissue, a tissue technology that delivers the combination of enhanced anti-calcification properties, improved sustained hemodynamic performance and dry storage;
  • A first-of-its-kind expandable frame, VFit technology also incorporates fluoroscopically visible size markers and is designed for potential future valve-in-valve procedures;
  • A valve platform built on the Carpentier-Edwards Perimount valve design.

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 nonstructural valve dysfunction. In addition, the European RESILIA tissue feasibility study, which initiated enrollment in 2011, underscores the safety and effectiveness of the Resilia 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, Oct. 7-11 in Vienna, Austria.

Plans are underway for a full U.S. launch of the INSPIRIS valve in early 2018. The valve became commercially available in Europe earlier this year.

For more information: www.edwards.com

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