FDA approves Abbott’s Epic Plus tissue valves for mitral and aortic valve replacement


Abbott has announced that the US Food and Drug Administration (FDA) has approved the company’s Epic Plus and Epic Plus Supra Stented Tissue Valves for aortic or mitral valve disease.

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.

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

“Doctors and patients have long depended on the Epic valve platform to help improve the quality of life for people in need of a surgical heart valve replacement,” said Vinayak Bapat, chief of Cardiothoracic Surgery at Abbott Northwestern Hospital (Minneapolis, USA). “With advancements made to Epic Plus, physicians can be assured of a reliable, longer-term solution for their patients needing a replacement heart valve that will also allow for future cardiac interventions if necessary due to the valve’s accommodating design.”

“Whether it is developing new treatment options or improving upon our existing proven therapies, Abbott is constantly striving to deliver innovative solutions to address life-threatening heart conditions,” said Michael Dale, senior vice president of Abbott’s structural heart business. ”This FDA approval affirms our commitment to advancement of the Epic Platform and our mission to help people live better lives through better health.”


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