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Friday, Apr 10, 2026

Edwards Gets European Approval for New Heart Valve

Irvine-based medical device maker Edwards Lifesciences Corp. said Wednesday that European regulators approved a new, larger version of its Sapien XT less-invasive heart valve.

Edwards said the latest Sapien XT increases the product’s availability to three sizes. It’s inserted through a small incision that a surgeon makes in a patient’s ribs.

Sapien and other less-invasive valves are considered one of the biggest advances in replacement heart valves in recent years.

The valves are expected to open up the market for a wider group of patients.

Edwards originally launched Sapien XT in Europe in 2010. In the U.S., Sapien XT is in a clinical trial.

The device maker is readying for a U.S. launch of its original Sapien valve that’s expected later this year.

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