FDA approves bovine tissue valve for surgical mitral valve replacement
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Edwards Lifesciences announced the FDA approved the Mitris Resilia surgical valve, a tissue valve replacement specifically designed for the heart's mitral position.
The Mitris Resilia valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve, according to a company press release. It also features a low-profile frame that helps avoid obstruction of the left ventricular outflow tract by stent posts and is visible under fluoroscopy, to facilitate potential future transcatheter interventions for patients.
"For patients who need mitral valve replacement, the advanced Mitris Resilia valve is based on a trusted pericardial valve platform, designed to mimic the native valve and incorporating tissue with integrity-preservation technology that will potentially allow the valve to last longer," Kevin Accola, MD, cardiovascular surgeon at AdventHealth Orlando, said in the release.
The therapy is the company's latest innovation offering advanced Resilia tissue with an anti-calcification technology that also allows devices to be stored under dry packaging conditions, facilitating ease of use, according to the company.
Resilia tissue is bovine pericardial tissue and serves as the platform for Edwards' new class of valves. The tissue has been studied in two premarket clinical trials. The COMMENCE enrolled 694 participants in an aortic arm and 83 participants in a mitral arm, with both groups followed for 5 years. The EU Feasibility trial enrolled 133 patients followed for 5 years.
"Mitral valve disease is prevalent and the patients impacted experience the disease in variable ways," Daveen Chopra, Edwards' corporate vice president, surgical structural heart, said in the release. "It was important to design the Mitris Resilia valve to perform like the native mitral valve, handling the highest pressures in the heart and offering sustained hemodynamic performance, so that surgeons and patients can have confidence in this new therapy option."
In addition to FDA approval, the Mitris Resilia valve has also received regulatory approval in Japan, Canada and other countries globally.
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