Medtronic plc received U.S. Food and Drug Administration (FDA) approval for its Mosaic Neo mitral bioprosthesis and has launched the valve in the U.S.
The updated valve is thoughtfully designed to be implanted through sternotomy, Minimally Invasive Cardiac Surgery (MICS), and robotic access, all of which were recently used when initial implants were performed at numerous centers across the United States. Medtronic’s original Mosaic valve for replacing malfunctioning native or prosthetic aortic and mitral heart valves received FDA premarket approval in 2000.
The first robotic implantation of the Mosaic Neo mitral valve was performed by Vinay Badhwar, M.D., and Executive Chair of the West Virginia University (WVU) Heart and Vascular Institute. The Mosaic Neo mitral valve will be officially launched at the American Association for Thoracic Surgeons (AATS) 106th Annual Meeting in Chicago this week.
“The Mosaic Neo mitral valve builds on the prior Mosaic platform, and the new intuitive sizers, strut suspension system, valve holder, and sewing cuff are all noticeable improvements,” said David H. Adams, M.D., Marie-Josée and Henry R. Kravis Professor and System Chairman of the Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai Hospital.
According to the company press release, the Mosaic Neo mitral valve combines enhanced user experience, excellent hemodynamics, and unsurpassed, industry-leading durability as demonstrated by the Mosaic mitral valve. To facilitate patient lifetime management, the Mosaic Neo mitral valve combines a reduced left ventricular stent post protrusion, a unique wide anterior distance between the stent posts, intuitive orientation markers and improved visualization under fluoroscopy to enable Left Ventricular Outflow Tract (LVOT) clearance and preservation of the neo-LVOT.
“I was very pleased with the implantation of the Mosaic Neo valve,” said Douglas R. Johnston, M.D., Chief of Cardiac Surgery at Northwestern Medicine Bluhm Cardiovascular Institute. “The reduced stent post protrusion and the wide distance between the anterior stent posts, combined with a very conformable sewing cuff, make the Mosaic Neo a favorable choice for the often challenging annular and LVOT anatomy we see currently in mitral valve replacement patients. With the proven durability of the Mosaic Mitral platform, the design enhancements of Mosaic Neo bring a much-needed option to the landscape of mitral valve replacement surgery.” With new features such as a low-profile valve holder and first-to-market small incision sizers, this next-generation device features innovative, surgeon-inspired enhancements specifically designed to improve ease-of-use both during open and minimally invasive surgery.
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