Medtronic is kicking off the nationwide rollout of the latest generation of its transcatheter aortic valve replacement system, the Evolut FX.
The TAVR implant first received approval to treat aortic stenosis from the FDA in August 2021 and has been available through a limited release that began earlier this year.
Like its predecessor, the Evolut PRO+, the self-expanding FX comes in four valve sizes to help fit a range of different patients. However the latest version, Evolut’s fourth, also includes updates such as radio-opaque gold markers that allow surgeons to directly visualize the proper alignment of the valve’s flaps during placement.
The Evolut FX also comes with a flexible delivery system that can rotate 360 degrees and a redesigned catheter tip for smoother insertion and more predictable deployments, according to the medtech giant. The new announcement was made during the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics conference, known as TCT.
Medtronic’s main TAVR competitor, Edwards Lifesciences, secured an FDA green light last week for the latest version of its Sapien 3 valve, updated with materials the company says can help the implant be more resistant to the build-up of calcium deposits and potentially have a longer lifespan.
Edwards’ Resilia technology—which will be incorporated in its future transcatheter heart valves—is built on treated bovine pericardial tissue that also allows the implant to last longer in dry storage. The company said it plans to begin making the Sapien 3 Ultra Resilia valve available in the U.S. through a limited release in the fourth quarter.
In 2019, the FDA broadened its approvals of past versions of Medtronic’s Evolut and Edwards’ Sapien TAVR implants to include patients with symptoms of severe narrowing of their aortic valves that would otherwise have a low risk of complications from open-heart surgery.
Prior to that, TAVR procedures—where the valve replacement is folded down and snaked through the body’s arteries before being placed within the heart—had been reserved for patients with higher risks of undergoing an open surgical procedure.