FDA Approves Self-Expanding TAVR System For Severe Aortic Stenosis Treatment

The updated transcatheter aortic valve replacement system incorporates a supra-annular valve design, with a redesigned catheter tip and 4 valve sizes.

The US Food and Drug Administration has approved the self-expanding transcatheter aortic valve replacement (TAVR) Evolut FX TAVR system.

The approval was granted to Medtronic.

The new TAVR system utilized both the hemodynamic and durability benefits of the Evolut platform in a new innovation for patients with symptomatic severe aortic stenosis.

Design

Patients with severe aortic stenosis face reductions in quality of life and limit of daily activities and if left untreated, the patient can die from heart failure as soon as 2 years.

The TAVR system integrates the supra-annular valve design that is considered to show a superior hemodyamic performance compared to SAVR in large-scale, randomized clinical trials.

It is built with gold markers in the frame to aid implanters with direct visualization of depth and valve leaflet location during implant. In addition, the redesign of the catheter tip benefits smoother insertion and 360-degree freedom of motion.

Similar to the previous system, the TAVR includes 4 valve sizes to accompany the largest indicated patient treatment range.

Reaction

Jeffrey Popma, MD, vice president and chief medical officer for Cornary & Renal Deservation and Structural Heart & Aortic at Cardiovascular Profile at Medtronic, noted in a statement that the supra-annular Evolut platform has evolved significantly over time, with a focus on innovative features including recapturability and advanced valve sealing.

“Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualization capabilities for orientation and depth," Popma said.

The TAVR platform is indicated for all risk categories of patients with symptomatic severe aortic stenosis patients in the US. A limited commercial release is expected in fall 2021, with a full launch expected in 2022.