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The Avalus Ultra valve is, at present, only commercially available in the U.S.
April 22, 2024
By: Sam Brusco
Associate Editor
Medtronic has launched its Avalus Ultra valve, its next-generation surgical aortic tissue valve. The company touted Avalus Ultra for its ease of implant, clear visibility for valve-in-valve procedures, and straightforward sizing. It features a low valve profile, as well as a PEEK baseframe, industry-leading Effective Orifice Area (EOA), and radiopaque coil. During a surgical aortic valve replacement (SAVR) for aortic valve disease, the surgeon makes an incision in the sternum to open the chest and expose the heart. The diseased native valve is removed, and a new artificial valve implanted. Once in place, it’s sewn into the aorta and replaces the original valve’s function so oxygen-rich blood can flow efficiently out of the heart. The Avalus Ultra valve earned U.S. Food and Drug Administration (FDA) approval in January 2024 and is, at present, only commercially available in the U.S. “Patients with aortic stenosis are experiencing more complex disease, and therefore, procedures need to evolve to optimize their surgical care,” said Professor Pieter Kappetein, VP and chief medical officer of Medtronic’s Cardiac Surgery, Structural Heart, and Mechanical Circulatory Support businesses. “Rooted in this evolving need, surgeons are demanding innovative technologies like the Avalus Ultra valve that is designed for increased ease of use and long-term durability to serve patients over their lifetime.” “Cardiac surgeons are looking to industry to partner with them to deliver improved innovation to treat their patients efficiently and effectively,” added Karim Bandali, Ph.D., president of Medtronic’s Cardiac Surgery business. “The Avalus Ultra valve builds on several successful innovation launches this year, including the acquisition and launch of the Penditure LAA Exclusion System. Aligned our Mission, Medtronic is committed to making the investments needed to advance and deliver innovative, lifesaving devices for better lifetime patient management.”
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