HLT’s Meridian TAVR Device Will Be Evaluated in Two FDA-Approved Clinical Studies

March 24, 2022—HLT Inc., a Bracco Group Company, announced that it has received FDA approval for two clinical studies to assess the performance and safety of the HLT Meridian transcatheter aortic valve replacement (TAVR) system to treat aortic stenosis and aortic regurgitation in high-risk patients with aortic disease.

According to the company, the Meridian TAVR system is designed to provide the benefits of both balloon-expandable and self-expanding platforms with a lower profile and nonobstructive design that reduces coronary and conduction obstruction. The system’s design seeks to increase hemodynamic performance to reduce the concern of patient-prosthesis mismatch.

The HLT Meridian TAVR valve system is pending clinical investigation that will be used to support future clearance or approval by the FDA. It is an investigational device not available for sale in any geography, advised the company.