FDA approves resilient heart valve

Edwards Lifesciences announced that its resilient aortic valve has been approved by the FDA for use as a heart valve replacement, according to a company press release.

The Inspiris Resilia aortic valve is indicated for patients who require replacement of the native or prosthetic aortic valve.

This valve is the first in a new class of resilient heart valves, according to the company.

The valve features Edwards Lifesciences’ Resilia tissue, which delivers anti-calcification properties, improved sustained hemodynamic performance and dry storage; an expandable frame that incorporates fluoroscopically visible size markers and is designed for potential future valve-in-valve procedures; and a platform built on the Carpentier-Edwards Perimount valve design, according to the release.

“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,” Joseph Bavaria, MD, Roberts-Measey professor and vice chief of cardiovascular surgery at the University of Pennsylvania, stated in the release.

The new approval was supported by results of the COMMENCE pivotal trial. Two-year data published in the European Journal of Cardio-Thoracic Surgery showed no cases of structural valve deterioration, valve thrombosis or nonstructural valve dysfunction in 689 patients undergoing surgical aortic valve replacement with the Inspiris Resilia valve, according to the release.

In addition, the European RESILIA tissue feasibility study, which initiated enrollment in 2011, demonstrated safety and effectiveness of the Resilia tissue. Four-year data from the European feasibility study will be presented at the European Association for Cardio-Thoracic Surgery annual meeting in October, according to the release.

“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,” John D. Puskas, MD, MSc, FACC, FACS, professor of cardiothoracic surgery at Icahn School of Medicine at Mount Sinai; chairman of the department of cardiothoracic surgery at Mount Sinai Saint Luke’s, Mount Sinai Beth Israel and Mount Sinai West (Roosevelt); and national principal investigator of the COMMENCE trial, stated in the release.

The valve received CE Mark in September 2016. The anticipated U.S. launch of the new valve is early 2018, according to the release.

Reference:

Puskas JD, et al. Eur J Cardiothorac Surg. 2017;doi:10.1093/ejcts/ezx158.

Disclosure: The COMMENCE trial is sponsored by Edwards Lifesciences.