On Wednesday, the FDA greenlit Medtronic plc’s MDT Evolut FX+ transcatheter aortic valve replacement (TAVR) system for symptomatic severe aortic stenosis.
The newest Evolut FX+ TAVR system retains the valve performance advantages of the earlier Evolut TAVR platform and is specifically engineered to enhance coronary access.
The Evolut FX+ TAVR system boasts larger coronary access windows through a redesigned diamond-shaped frame, a significant four times larger than its predecessors under the Evolut TAVR system umbrella.
By providing more space for catheter maneuverability, the Evolut FX+ enables improved access to coronary arteries in patients with diverse anatomical structures.
In cases of severe aortic stenosis, the aortic valve leaflets thicken and stiffen, impeding their ability to open and close effectively, thereby forcing the heart to exert more effort to pump blood throughout the body.
The Evolut FX+ TAVR system is suitable for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the U.S. Early Commercial Experience is set for spring 2024, with a full product release anticipated in summer 2024.
In a strategic move during February, Medtronic opted to discontinue its ventilator product line while consolidating its residual Patient Monitoring and Respiratory Interventions (PMRI) businesses into a unified entity known as Acute Care and Monitoring (ACM).
Exiting the waning ventilator segment and merging the remaining businesses will facilitate increased investment in ACM, with a focus on sustainable growth.
In December, the FDA granted approval for Medtronic’s PulseSelect Pulsed Field Ablation System to treat paroxysmal and persistent atrial fibrillation, a common form of irregular and rapid heart rhythm.
PulseSelect is the inaugural PFA technology to secure U.S. approval and the only PFA technology with FDA breakthrough designation to garner endorsement following the recent European CE Mark accreditation of the PulseSelect PFA system in November.
Price Action: MDT shares surged by 2.95% to $86.17 in the latest update on Wednesday.
Photo by Tony Webster via Wikimedia Commons
