Medtronic's Latest Generation Of Transcatheter Aortic Valve Replacement Implant Passes FDA's Muster, Shares Gain

Wednesday, the FDA approved Medtronic plc’s MDT Evolut FX+ transcatheter aortic valve replacement (TAVR) system for symptomatic severe aortic stenosis. 

The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.

The Evolut FX+ TAVR system offers larger coronary access windows through a modified diamond-shaped frame design, which is four times larger than previous iterations of the Evolut TAVR system. 

Evolut FX+ provides increased space for catheter maneuverability to facilitate access to coronary arteries of varying patient anatomies. 

Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. 

The Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the U.S. Early Commercial Experience is planned for spring 2024, with a full product launch anticipated in summer 2024.

In February, Medtronic decided to exit its ventilator product line and retain and combine the remaining Patient Monitoring and Respiratory Interventions (PMRI) businesses into one unit called Acute Care and Monitoring (ACM). 

Exiting the increasingly unprofitable ventilator product line and combining the remaining businesses allows for increased investment in ACM with a focus on profitable growth. 

In December, the FDA approved Medtronic’s PulseSelect Pulsed Field Ablation System for the treatment of both paroxysmal and persistent atrial fibrillation, an irregular and often very rapid heart rhythm.

PulseSelect is the first PFA technology approved for use in the U.S. and the first PFA technology with FDA breakthrough designation to win approval following the recent European CE Mark of the PulseSelect PFA system in November.

Price Action: MDT shares are up 2.95% at $86.17 on the last check Wednesday.

Photo by Tony Webster via Wikimedia Commons