FDA Approves Medtronic's Mosaic Neo Mitral Valve as US Launch Begins

Medtronic has received US Food and Drug Administration approval for its Mosaic Neo mitral bioprosthesis and has launched the surgical heart valve in the US, the company said in an April 29 release.

A mitral bioprosthesis is a replacement valve made from animal tissue that surgeons sew in place of a diseased mitral valve, which controls blood flow between the heart's left upper and lower chambers. Medtronic said almost 20,000 patients undergo surgical mitral valve replacement in the US each year.

A supplement to a long-standing PMA

The FDA's premarket approval database lists the Mosaic Neo Mitral Bioprosthesis as supplement S094 to PMA P990064, held by Medtronic, Inc., at a Santa Ana, California, address. The agency received the supplement on September 4, 2025, and approved it on March 3, 2026, on the normal 180-day track. The record lists the reason as a change in design, components, specifications or material, with no expedited review. Its approval order statement reads: "approval for updates to the sewing cuff, suture markings, radiopaque marker, holder, and sizers."

The original Mosaic porcine valve received FDA premarket approval in 2000 for replacing aortic and mitral valves, MedTech Dive reported. A Medtronic spokesperson told the publication that Mosaic Neo is the only mitral valve constructed from a full native porcine valve.

First implants and company claims

Medtronic said the valve is designed to be implanted through a sternotomy, through minimally invasive cardiac surgery or with robotic access, and that all three approaches were used in initial US cases. It said David H. Adams of Mount Sinai Hospital in New York implanted the first Mosaic Neo valves worldwide, Vinay Badhwar of West Virginia University performed the first robotic implant, and Gorav Ailawadi of University of Michigan Health performed the first procedure combining the valve with Medtronic's Penditure left atrial appendage exclusion system.

"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 the release. The release discloses that Adams is the inventor of a Medtronic annuloplasty ring and that Ailawadi has a paid relationship with Medtronic; it says the surgeons quoted were not paid for their quotes.

The company said the valve has a reduced stent post protrusion into the left ventricle, a wide distance between the front stent posts and improved visibility under fluoroscopy, features it said are meant to keep the outflow tract clear for possible future procedures. A footnote in the release states: "The benefits of the Mosaic Neo valve atrialized design have been demonstrated through bench testing. No direct clinical evaluation in humans has been conducted."

Medtronic said it plans a formal launch at the American Association for Thoracic Surgery annual meeting in Chicago, May 2-5. MedTech Dive noted that competitors Abbott and Edwards Lifesciences make transcatheter mitral repair and replacement devices.