Feasibility Study Evaluates HLT’s Meridian TAVR Device and Pathfinder II Delivery System
April 10, 2017—HLT, Inc. recently announced the first patient enrollments in a feasibility clinical study to assess the safety and performance outcomes of the company's Meridian transcatheter aortic valve replacement device and Pathfinder II delivery system in patients with severe aortic stenosis at high risk for surgery. The implantation procedures were performed by Josep Rodés-Cabau, MD, et al at Quebec Heart and Lung Institute in Quebec City, Quebec.
In the company's announcement, Dr. Rodés-Cabau commented, “The Meridian valve allows us to evaluate complete valve function before releasing it from the delivery system. The valve was easy to implant and the overall procedure was predictable. Hemodynamic stability was maintained throughout the entire procedure, including the time of valve implant.” Dr. Rodés-Cabau is Director of Catheterization and Interventional Laboratories at the Quebec Heart and Lung Institute.
The RADIANT trial is a prospective, nonrandomized, single-arm, multicenter study that will enroll up to 20 high-risk patients with severe aortic valve stenosis. The endpoint will evaluate all-cause mortality at 30 days after implantation of the Meridian transcatheter aortic valve. Patient follow-up will occur at 1, 6, and 12 months, and annually to 5 years.
The self-expanding Meridian transcatheter aortic valve has a flexible wire frame that supports the valve’s leaflets and is designed to promote good flow characteristics and reduce stress on the leaflet tissue for long-term performance.
The Meridian device is designed to conform to the natural structure of the heart, and its Pathfinder II delivery system provides physicians control over valve placement in a beating heart, as well as flexibility to reposition or fully retrieve the valve and fully assess the valve’s function before final release.