FDA Approves Edwards Lifesciences' Resilia Valve For Mitral Replacement Surgery

The FDA has approved Edwards Lifesciences Corp's EW Mitris Resilia 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.
It also features a low-profile frame that helps avoid the left ventricular outflow tract obstruction by stent posts and is visible under fluoroscopy to facilitate future transcatheter interventions.
Related: Edwards Lifesciences Q4 Earnings Fall Short Of Expectations, Reaffirms FY22 Outlook.
Resilia tissue is bovine pericardial tissue and serves as the platform for Edwards' new class of valves.
Resilia tissue has been studied in two premarket clinical trials, including the COMMENCE trial in 694 patients enrolled in an aortic arm, and the EU Feasibility trial comprised 133 patients enrolled who were followed for five years.
Price Action: EW shares are up 1.27% at $118.58 during the market session on the last check Thursday.

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