Abbott has secured FDA clearance for its Epic Max stented tissue valve. Credit: Abbott.

Abbott has received approval from the US Food and Drug Administration (FDA) for its Epic Max stented tissue valve to treat aortic valve disease.

Part of the company’s Epic surgical valve platform, the Epic Max valve is intended for the treatment of people with aortic regurgitation or stenosis.

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Designed to attain better haemodynamics, or blood flow, Epic Max features a low-profile frame that enables potential future transcatheter interventions for patients.

According to the company, bioprosthetic valves, such as Epic Max, can be used for patients who require valve replacement but cannot take blood-thinning medication.

Mechanical or bioprosthetic (tissue) valves will be used to replace diseased or damaged heart valves that cannot be repaired in an open-heart surgical procedure.

Abbott structural heart business senior vice-president Michael Dale said: “With Epic Max, we’re accomplishing two important things: First and foremost, we’re improving heart valve hemodynamics, which is the purpose of the procedure.

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“Secondly, we’re preserving options and ability for patient lifetime disease management, an ever more critical point of consideration in device therapy selection.”

University of Pennsylvania cardiovascular surgery division vice-chief Dr Joseph Bavaria said: “The aortic valve is one of the heart valves most commonly impacted by cardiovascular disease, frequently requiring replacement.

“Abbott’s Epic Max design optimises blood flow for patients and has a low profile that makes future cardiac interventions, if necessary, easier.”

In another development this month, Abbott announced positive late-breaking data from the TRILUMINATE Pivotal trial of its TriClip transcatheter edge-to-edge repair (TEER) system.