HLT said today that it launched a feasibility trial of its Meridian TAVR in a high-risk patient cohort.
Maple Grove, Minn.-based HLT said the 20-patient Radiant study is a prospective, non-randomized, single-arm trial with an endpoint of all-cause mortality at 30 days. Follow-up is slated for 1, 5 and 12 months after implantation, and then annually to 5 years. The 1st implantations in the trial were performed at the Quebec Heart & Lung Institute, the company said. HLT, which is owned by Milan-based Bracco Group, is a sister company of advanced contrast delivery and cardiology imaging systems maker Acist Medical Systems.
“The Radiant clinical study will provide evidence regarding the safety and performance of a 3rd-generation transcatheter aortic valve replacement therapy,” HLT general manager Kevin Bassett said in prepared remarks. “We’re delighted to partner in the study with outstanding clinicians at the Quebec Heart & Lung Institute as well as the Sunnybrook Health Science Center in Toronto.”
“The Meridian valve allows us to evaluate complete valve function before releasing it from the delivery system,” added Dr. Josep Rodés-Cabau, who performed the 1st implantations in the trial. “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.”
The self-expanding Meridian device is designed to be put in place using HLT’s Pathfinder delivery system, which physicians can use to re-position or retrieve the valve and assess its function ahead of final implantation.