USA — Abbott has made an announcement regarding the approval of its Epic Max stented tissue valve by the U.S. Food and Drug Administration (FDA) to treat individuals suffering from aortic regurgitation or stenosis.
This new valve is the most recent addition to Abbott’s Epic surgical valve platform, which has been established for several decades and has a proven track record of safety and clinical success.
Furthermore, the valve has an optimized design that improves blood flow, which is a vital aspect of valve performance.
Aortic regurgitation or stenosis is a condition in which the aortic valve doesn’t close properly or fails to open fully, resulting in reduced blood flow to the body and a lack of efficient blood pumping by the heart.
If left untreated, aortic valve disease can lead to severe consequences such as heart failure, stroke, blood clots, or death.
The only treatment option for diseased or damaged heart valves that can’t be repaired is surgical replacement with either mechanical or bioprosthetic (tissue) valves in an open-heart procedure.
Bioprosthetic valves such as the Epic Max are recommended for patients who need valve replacement but can’t take blood-thinning medication.
Epic Max is engineered to achieve excellent blood flow (hemodynamics), and its low-profile frame makes potential future transcatheter interventions more accessible for patients.
This new valve is built on the Epic surgical valve platform, which leverages its long-term performance and durability.
According to Joseph E. Bavaria, M.D., a cardiovascular surgeon at the University of Pennsylvania, “the aortic valve is one of the heart valves most commonly impacted by cardiovascular disease, frequently requiring replacement.”
He further commented that “Abbott’s Epic Max design optimizes blood flow for patients and has a low profile that makes future cardiac interventions, if necessary, easier.”
Michael Dale, senior vice president of Abbott’s structural heart business, noted that “with Epic Max, we’re accomplishing two important things: First and foremost, we’re improving heart valve hemodynamics, which is the purpose of the procedure.”
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.
AS poses a significant burden to healthcare systems, with an estimated 1.5 million patients affected in the US alone, including 500,000 with severe-stage disease and 250,000 with symptoms. As the population ages, this burden is expected to increase.
In addition, the high costs associated with AS are a major concern, with a recent study estimating that aortic valve disease contributes to an annual incremental healthcare spending of US$10.2 billion in the U.S.
While there is limited data on AS diagnosis rates, estimates can be made based on prevalence data from population-based studies.
In Europe alone, it is estimated that there are a significant number of AS cases, ranging from mild to severe.
To address this, early diagnosis and intervention are crucial to prevent disease progression and associated costs.
A recent study by Veronesi and colleagues looked at the costs of treating patients with aortic stenosis (AS).
They found that patients who received surgery to replace a damaged valve had much lower costs than those who did not.
In fact, the costs for patients who received surgery decreased from 28,365 euros (about US$30,840) to 8,002 euros (about US$8,700).
This highlights how expensive it can be to care for patients with severe AS who need to go to the hospital repeatedly and receive treatments for heart failure.
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