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Home » Abbott wins FDA nod for Epic Max stented tissue valve

Abbott wins FDA nod for Epic Max stented tissue valve

March 30, 2023 By Sean Whooley

Abbott Epic Max stented tissue valve
The Epic Max stented tissue valve. [Image courtesy of Abbott]
Abbott (NYSE:ABT) announced today that the FDA approved its Epic Max stented tissue valve for treating aortic regurgitation or stenosis.

The latest addition to Abbott’s Epic surgical valve platform features an optimized design to further improve blood flow. In 2021, the FDA approved the next-generation Epic Plus and Epic Plus Supra stented tissue valves.

Epic Max, a bioprosthetic valve, offers a valve replacement option for patients who aren’t suitable for blood-thinning medication. Abbott designed it to achieve “excellent hemodynamics,” the company said in a news release. The device’s low-profile frame facilitates potential future transcatheter interventions for patients, too.

Dr. Joseph E. Bavaria, a cardiovascular surgeon from the University of Pennsylvania, said Epic Max “optimizes blood flow.” He added that the low profile makes potential future cardiac interventions easier.

Abbott said it built the latest Epic valve upon its longstanding platform, leveraging long-term performance and durability. The company designed the valve to preserve and facilitate future options for lifetime heart valve disease management. It treats people with a leaky or narrowed aortic valve.

“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. Secondly, we’re preserving options and ability for patient lifetime disease management, an ever more critical point of consideration in device therapy selection,” said Michael Dale, SVP of Abbott’s structural heart business.

Filed Under: Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Implants, News Well, Regulatory/Compliance, Replacement Heart Valves, Structural Heart Tagged With: Abbott, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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