FDA approves Abbott’s Epic Plus Tissue Valves for people in need of mitral or aortic valve replacement

September 22, 2021  –  Abbott (Abbott Park, IL) announced that the U.S. Food and Drug Administration (FDA) approved the company’s Epic Plus and Epic Plus Supra Stented Tissue Valves to improve therapy options for people with aortic or mitral valve disease.

These next-generation devices build off Abbott’s Epic surgical valve platform and include innovations that make implantation of the valve and future cardiac interventions easier, the company says.

Enhancements to Epic Plus include more radiopaque markers (reference points that are visible on radiographic scans) that make it easier for doctors to navigate if future transcatheter procedures are needed.

The new valves are designed to deliver long-term performance and durability due to Abbott’s unique anticalcification technology. The Epic Plus Mitral holder, which helps to ensure precise insertion of the valve, has a lower profile so physicians have a better view of the device for accurate placement during implantation. The device can be implanted in the aortic or mitral valve position and in patients with more complicated anatomies.

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