An Epic success: FDA approves Abbott's upgraded, longer-lasting replacement mitral valve

With a green light from the FDA, Abbott is scaling up its replacement mitral and aortic valve portfolio to epic proportions—or, more specifically, to Epic Plus proportions.

The upgraded edition of the longstanding Epic line of stented tissue valves has been approved by the FDA, clearing them for use in procedures to replace blocked or damaged heart valves. The newly approved devices include the Epic Plus valve, which can replace either aortic or mitral valves—whether they’re patients' native valves or previous implants—and the Epic Plus Supra valve, which is used only in aortic valve replacements.

The aortic valve is located between the left ventricle and the aorta, while the mitral valve is found between the left ventricle and the left atrium. If the valves either become too stiff or narrowed to let blood flow through or are unable to close properly, sending blood flowing the wrong way, the malfunctioning valve can lead to heart failure, stroke, blood clots or death, and therefore must be either repaired or replaced.

RELATED: Abbott nets EU approval for next-gen MitraClip heart valve repair system

That’s where the Epic replacements come in. The stented tissue valves are composed of a polymer stent surrounded by a flexible, silicone-filled cuff to fit seamlessly into the heart and facilitate normal blood flow. The bioprosthetic valves are also equipped with porcine leaflets to mitigate the body’s natural rejection of implanted foreign objects and have a low stent post height so they don’t block the flow of blood out of the left ventricle.

Abbott’s new devices achieve their “Plus” title with the addition of more radiopaque markers that can be spotted on imaging scans to improve post-implant monitoring. They’re also constructed with new anti-calcification technology, to last longer. Finally, the accompanying insertion device is smaller than previous models, giving surgeons a clearer view of the replacement valve throughout the implant process.

The devices represent an upgrade to the replacement valve options for the more than 100,000 people in the U.S. who undergo heart valve surgeries each year, according to Abbott. Full valve replacements, rather than repair procedures, allow older patients and other at-risk groups to avoid the long-term use of blood thinners that’s required after other forms of treatment for aortic or mitral regurgitation or stenosis.

The Epic devices are the most widely used replacement mitral valves in these procedures around the world, the company said. They received their first FDA approval in 2007, while still under the jurisdiction of original developer St. Jude Medical, and were folded into Abbott’s bioprosthetic and mechanical heart valve portfolio in its $25 billion acquisition of St. Jude in 2017.

RELATED: Abbott snaps up replacement mitral valve maker Cephea

That acquisition was sandwiched between two others that further expanded Abbott’s replacement heart valve offerings. In 2015, it scooped up Tendyne for $225 million and has since scored a first-of-its-kind European approval for the Tendyne transcatheter mitral valve implantation system, an alternative to typical valve repair options.

At the same time, Abbott set up an option with Cephea Valve Technologies allowing it to acquire the minimally invasive replacement valve maker down the line—an option it finally exercised in 2019, bringing Cephea’s MitraClip repair devices under the Abbott umbrella.