HLT has announced that the first patient implants in a feasibility clinical study to assess the safety and performance outcomes of its Meridian transcatheter aortic valve and Pathfinder II delivery system in patients with severe aortic stenosis at high risk for surgery.
The implants were completed at Quebec Heart and Lung Institute in Quebec City, Canada, by Josep Rodés-Cabau, and his team.
“The Meridian valve allows us to evaluate complete valve function before releasing it from the delivery system,” says Rodés-Cabau, director of Catheterization and Interventional Laboratories at the Quebec Heart and Lung Institute. “The valve was easy to implant and the overall procedure was predictable. Haemodynamic stability was maintained throughout the entire procedure, including the time of valve implant.”
The RADIANT trial is a prospective, non-randomized, single-arm, multicentre study that will enrol up to 20 high-risk patients with severe aortic valve stenosis. The endpoint will evaluate all-cause mortality at 30 days after implant of the Meridian transcatheter aortic valve. Patient follow-up will occur at one, six and 12 months and annually to five years.
HLT’s Meridian transcatheter valve is self-expanding. As in surgical valve designs, a flexible wire frame supports the valve’s leaflets which is designed to promote good flow characteristics and reduce stress on the leaflet tissue for long-term performance.
HLT’s Pathfinder delivery system is intended to provide physicians confidence in positioning the valve. Specifically, it is designed to allow them to reposition or retrieve the valve if necessary and most importantly fully assess the valve’s function prior to its final release in the heart.