Abbott’s Epic Max stented tissue aortic valve gains US FDA approval

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Abbott Logo (PRNewsFoto/Abbott)

Abbott has announced that the US Food and Drug Administration (FDA) has approved the company’s Epic Max stented tissue valve to treat people with aortic regurgitation or stenosis.

Epic Max is designed to achieve excellent haemodynamics, or blood flow, and its low-profile frame facilitates potential future transcatheter interventions for patients, Abbott said in a press release. This new valve is built on the Epic surgical valve platform, leveraging its long-term performance and durability.

“The aortic valve is one of the heart valves most commonly impacted by cardiovascular disease, frequently requiring replacement,” said Joseph Bavaria (University of Pennsylvania, Philadelphia, USA). “Abbott’s Epic Max design optimises blood flow for patients and has a low profile that makes future cardiac interventions, if necessary, easier.”

“With Epic Max, we are accomplishing two important things: First and foremost, we are improving heart valve haemodynamics, which is the purpose of the procedure. Secondly, we are preserving options and ability for patient lifetime disease management, an ever more critical point of consideration in device therapy selection,” said Michael Dale, senior vice president of Abbott’s structural heart business.


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