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Abbott Announces US FDA Approval for Epic™ Max Tissue Valve

Friday, March 31, 2023

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company's Epic™ Max stented tissue valve to treat people with aortic regurgitation or stenosis. This device is the latest addition to Abbott's Epic surgical valve platform which has a decades-long history of safety and strong clinical outcomes, with an optimised design to further improve valve blood flow.

•    Epic Max provides excellent blood flow for patients who need heart valve replacement
•    The new valve is designed to preserve and facilitate future patient options for lifetime management of their heart valve disease
•    Epic Max builds on the trusted safety and durability of Abbott's Epic surgical valve platform to treat people with a leaky or narrowed aortic valve

The aortic valve is one of the heart valves most commonly impacted by cardiovascular disease, frequently requiring replacement. Epic Max design optimises blood flow for patients and has a low profile that makes future cardiac interventions, if necessary, easier.