Abbott scores FDA green light for latest surgical aortic valve replacement implant

Though the less-invasive approaches to treating damaged heart valves have made large strides in recent years, sometimes open cardiac surgery is a patient’s best option. Now, Abbott has added to this portion of its portfolio.

The company received an approval from the FDA for the latest in its Epic line of bioprosthetic surgical implants, designed for patients with a leaky or narrowed aortic valve. Dubbed the Epic Max, the stented, tissue-based valve is recommended for patients who need a replacement but shouldn’t take a regimen of blood thinners.

According to Abbott’s announcement, the Epic Max also features a low-profile frame, to not get in the way of any future transcatheter-based heart procedures and preserve the patient’s options for heart valve management over the course of their lifetime.

The green light for the Epic Max follows Abbott’s September 2021 approval for the Epic Plus, an upgrade to the company’s long-running line of heart valves. That included devices for replacing the aortic valve—which helps direct blood from the left ventricle out to the rest of the body—as well as its nearby mitral valve, which lets in oxygenated blood from the lungs.

Both the Plus and the Max were approved for cases of regurgitation, where blood begins to churn backward through the valve, and stenosis that narrows the size of the opening and hampers blood flow.

Abbott recently joined with the FDA to urge caution with certain previous generations of bioprosthetic aortic valve replacements—which, as opposed to mechanical valves, and like the Epic Max, are built from animal tissue to help lessen the risk of blood clots.

In letters sent to healthcare providers in late February, Abbott and the agency described how an analysis showed its Trifecta line of valves may begin deteriorating within five years of implantation, possibly requiring surgery to remove and replace the implant.

Abbott acquired the product line when it bought out St. Jude Medical in 2017; the original Trifecta valve was approved by the FDA in 2011 but is no longer on U.S. shelves. A second-generation valve, the Trifecta GT, was approved in 2016.