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Wednesday, May 20, 2026

FDA OK’s Edwards Heart Valve

Edwards Lifesciences Corp. said Wednesday that the Food and Drug Administration approved its heart valve for treating mitral valve disease.

Irvine-based Edwards said the Perimount Magna mitral valve will be launched immediately.

Perimount Magna is a cow-tissue device that replaces a patient’s diseased mitral valve, which is between the heart’s left atrium and left ventricle. Edwards originally launched Perimount Magna in Europe in 2005.

Meanwhile, Edwards continues a key clinical trial for its Sapien heart valve, which is delivered to the heart through a catheter.

Some analysts have said Sapien, if it gets FDA approval, could be a potential blockbuster for the device maker. Sapien was launched in Europe at the end of last year.

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