ABBOTT RECEIVES FDA APPROVAL FOR EPIC MAX TISSUE VALVE

Abbott recently announced that the U.S. Food and Drug Administration (FDA) has approved the company's Epic™ Max stented tissue valve to treat people with aortic regurgitation or stenosis. This device is the latest addition to Abbott's Epic surgical valve platform which has a decades-long history of safety and strong clinical outcomes, with an optimized design to further improve valve blood flow.

When the aortic valve doesn't close properly (aortic regurgitation) or fails to open fully (aortic stenosis), the heart doesn’t pump blood efficiently and blood flow to the body is reduced. If left untreated, aortic valve disease can lead to heart failure, stroke, blood clots or death. Diseased or damaged heart valves that can't be repaired may be surgically replaced with either mechanical or bioprosthetic (tissue) valves in an open-heart surgical procedure. Bioprosthetic valves like Epic Max are recommended for patients requiring valve replacement who aren't suitable for taking blood-thinning medication.

Epic Max is designed to achieve excellent hemodynamics, or blood flow, and its low-profile frame facilitates potential future transcatheter interventions for patients. This new valve is built on the Epic surgical valve platform, leveraging its long-term performance and durability.