FDA Approves Abbott’s Epic Max Tissue Valve for Aortic Valve Disease

Abbott Labs has received U.S. Food and Drug Administration (FDA) approval for its Epic Max stented tissue valve to treat patients with aortic regurgitation or stenosis.
 
Bioprosthetic valves like Epic Max are recommended for patients needing valve replacement who aren’t suitable for taking blood-thinning medication. Epic Max was engineered to achieve excellent hemodynamics, according to Abbott, and it’s low-profile frame facilitates possible future transcatheter interventions.
 
“The aortic valve is one of the heart valves most commonly impacted by cardiovascular disease, frequently requiring replacement,” Joseph E. Bavaria, MD, cardiovascular surgery, University of Pennsylvania, told the press. “Abbott’s Epic Max design optimizes blood flow for patients and has a low profile that makes future cardiac interventions, if necessary, easier.”
 
“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. Secondly, we’re preserving options and ability for patient lifetime disease management, an ever more critical point of consideration in device therapy selection,” added Michael Dale, senior vice president of Abbott’s structural heart business.
 
Epic Max builds on Abbott’s Epic surgical valve platform, which has a decades-long history of safety and strong clinical outcomes. The surgical valve platform has also demonstrated long-term performance and durability.