Abbott has secured the US Food and Drug Administration (FDA) approval for its Epic Max stented tissue valve to treat people with aortic regurgitation or stenosis.
The company said that Epic Max is the latest addition to its Epic surgical valve platform, which has been delivering safety and clinical outcomes for decades.
Epic Max is designed based on its Epic surgical valve platform, using its long-term performance and durability.
The valve system delivers superior haemodynamics, and its low-profile frame facilitates potential future transcatheter interventions for patients, said Abbott.
The University of Pennsylvania cardiovascular surgery Joseph E Bavaria said: “The aortic valve is one of the heart valves most commonly impacted by cardiovascular disease, frequently requiring replacement.
“Abbott’s Epic Max design optimises blood flow for patients and has a low profile that makes future cardiac interventions, if necessary, easier.”
Abbott structural heart business senior vice president Michael Dale said: “With Epic Max, we’re accomplishing two important things: First and foremost, we’re improving heart valve haemodynamics, which is the purpose of the procedure.
“Secondly, we’re preserving options and ability for patient lifetime disease management, an ever more critical point of consideration in device therapy selection.”
According to the company, aortic regurgitation occurs when the aortic valve fails to close properly, and aortic stenosis when the aortic valve fails to open fully.
The two conditions result in insufficient blood supply, and reduced blood flow to the body parts, and may lead to heart failure, stroke, blood clots or death if left untreated.
The damaged heart valves that cannot be repaired may be surgically replaced with either mechanical or bioprosthetic (tissue) valves, through an open-heart surgical procedure.
Abbott said that bioprosthetic valves, such as its Epic Max are recommended for patients who need a valve replacement, but are not eligible for taking blood-thinning medication.
In September 2021, Abbott received FDA approval for its Epic Plus and Epic Plus Supra Stented Tissue Valves to support aortic or mitral valve disease treatment.
Epic Plus is also a bioprosthetic valve indicated for patients who require the replacement of a malfunctioning aortic or mitral heart valve.
