Medtronic Launches Mosaic Neo Mitral Valve in U.S. Following FDA Approval

Medtronic has secured approval from the U.S. Food and Drug Administration for its next-generation Mosaic Neo mitral valve and has begun its U.S. rollout.

The bioprosthetic valve is designed for surgical implantation via sternotomy or minimally invasive approaches. Built on the earlier Mosaic platform, Mosaic Neo uses a full native porcine valve, a feature the company highlights as key to its performance. The device is intended to treat mitral regurgitation, a condition in which the heart valve does not close properly, leading to backward blood flow and increased cardiac strain.

Medtronic also reported performing its first concomitant procedure combining the valve with its Penditure left atrial appendage exclusion device, aimed at reducing stroke risk by preventing clot formation.

Initial implants have already been completed across multiple U.S. centres, including a first robotic-assisted procedure. The company plans an official showcase at an upcoming surgical meeting, positioning the device within a competitive landscape that includes offerings from Abbott and Edwards Lifesciences.

04-05-2026