FDA Approves Abbott’s Epic Plus Tissue Valves Use In Mitral or Aortic Valve Replacement

by Sloan T. Wilson, The Chicago Times

September 28, 2021

GREEN OAKS, IL — The Epic Plus and Epic Plus Supra Stented Tissue Valves from Abbott have been approved by the US Food and Drug Administration (FDA) to improve therapy options for people with aortic or mitral valve disease.  These next-generation devices are based on Abbott’s Epic surgical valve platform, which has a long history of safety and good clinical outcomes and include innovations that make valve implantation and future cardiac interventions easier.

Heart valve disease occurs when one or more of the heart’s four valves fails to open or close properly, causing blood flow to the body to be disrupted. The aortic and mitral valves are the most commonly affected.  When diseased or damaged heart valves cannot be repaired, they can be surgically replaced with mechanical or bioprosthetic (tissue) valves during an open-heart surgery.  Epic Plus bioprosthetic valves do not require long-term use of blood-thinning medication, making them the preferred option for people who cannot take blood thinners or are over the age of 70.

Every year, over 100,000 people in the United States undergo conventional heart valve surgery, which is often a life-saving procedure.  The new Epic Plus tissue valves’ approval provides an important treatment option for patients undergoing valve replacement surgery without the need for long-term blood thinners, as well as a durable solution that allows for reinterventions as needed.

More radiopaque markers (reference points visible on radiographic scans) have been added to Epic Plus, making it easier for doctors to navigate if future transcatheter procedures are required.

The new valves, like the Epic surgical valve platform, are designed to provide long-term performance and durability thanks to Abbott’s proprietary anticalcification technology.

The Epic Plus Mitral holder, which aids in the precise insertion of the valve, also has a lower profile, allowing physicians a better view of the device during implantation.  The device can be implanted in either the aortic or mitral valve position, as well as in patients with more complex anatomies.

The Epic Plus Stented Tissue Valves are the newest addition to Abbott’s surgical tissue and mechanical heart valve portfolio.