Medtronic to Fully Launch Evolut FX TAVR System

Medtronic has expanded the U.S. market release of its Evolut FX transcatheter aortic valve replacement (TAVR) system following a limited launch earlier this year.

The new Evolut system includes additional features that enhance its ease of use and enables more predictable valve deployment, the company said. New features include markers built into the frame to provide implanters with direct visualization of the alignment, a redesigned catheter tip for smoother insertion and a more flexible delivery system.

The system is indicated for relief of aortic stenosis in patients with symptomatic heart disease who are judged appropriate for the transcatheter heart valve replacement therapy. It is also indicated for patients with symptomatic heart disease due to failure of a surgical bioprosthetic aortic valve who are judged to be at high risk for open surgical therapy.

Medtronic said the self-expanding TAVR system will now be made available to all commercial TAVR sites across the U.S.