FDA approves next-gen mitral valve from Medtronic
Medtronic has secured U.S. Food and Drug Administration (FDA) approval for the Mosaic Neo mitral valve, its next-generation mitral bioprosthesis that can be implanted through sternotomy, minimally invasive cardiac surgery (MICS) or robotic access.
The Mosaic Neo mitral valve was developed using years of feedback from veteran surgeons. It includes a low-profile valve holder and small incision sizers not seen on previous Medtronic valves. Another key feature is the device’s improved visibility under fluoroscopy, which makes left ventricular outflow tract clearance possible.
David H. Adams, MD, system chairman of the department of cardiovascular surgery with the Icahn School of Medicine at Mount Sinai Hospital, was the first surgeon in the world to implant the Mosaic Neo mitral valve. Vinay Badhwar, MD, executive chair of the West Virginia University Heart and Vascular Institute, performed the first robotic implantation of the device.
“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,” Adams said in a statement.
“I was very pleased with the implantation of the Mosaic Neo valve,” added Douglas R. Johnston, MD, chief of cardiac surgery at Northwestern Medicine Bluhm Cardiovascular Institute and another early user of the device. “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.”
Medtronic is officially launching the Mosaic Neo mitral bioprosthesis at the American Association for Thoracic Surgeons Annual Meeting in Chicago on May 2–5.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.