Abbott’s tissue valves obtain FDA approval for mitral valve replacement
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Abbott’s tissue valves obtain FDA approval for mitral valve replacement

23 Sep 2021 (Last Updated September 23rd, 2021 12:45)

Developed with the Epic surgical valve platform, the valves could facilitate valve placement and future cardiac interventions.

Abbott’s tissue valves obtain FDA approval for mitral valve replacement
Heart valve disease occurs when one or more valves does not open or close well, impacting blood flow to the body. Credit: jesse orrico / Unsplash.

The US Food and Drug Administration (FDA) has approved Abbott’s Epic Plus and Epic Plus Supra Stented Tissue Valves to boost treatment options for individuals with aortic or mitral valve disease.

These advanced devices are developed using the company’s Epic surgical valve platform and include improvements that simplify both the valve placement and future cardiac interventions.

Improvements to Epic Plus consist of additional radiopaque markers or reference points that are detectable on radiographic scans, making navigation easier for doctors in potential future transcatheter procedures.

A broadly used mitral tissue heart valve in the US and worldwide, Epic valve can enhance implantation and permit compatibility for any prospective transcatheter valve procedures.

In line with the Epic surgical valve platform, the latest valves are created to offer lasting performance and durability thanks to Abbott’s anti-calcification technology.

The Epic Plus Mitral holder, which aids in guaranteeing accurate implantation of the valve, also has a reduced profile that grants doctors an improved view of the device during placement.

The device is intended for implantation in the aortic or mitral valve positions and is suitable for patients with sophisticated anatomies.

Abbott structural heart business senior vice-president Michael Dale said: “Whether it’s 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.

“This FDA approval affirms our commitment to the advancement of the Epic Platform and our mission to help people live better lives through better health.”

The company noted that the Epic Plus Stented Tissue Valves are the newest addition to its portfolio of surgical tissue and mechanical heart valves.

The development comes after the FDA approved Abbott’s Portico with FlexNav transcatheter aortic valve replacement system to treat individuals with symptomatic, severe aortic stenosis.