FDA approves two clinical trials for HLT’s TAVR system

Maple Grove, Minnesota-based HLT, a Bracco Group Company, will conduct the studies to assess the performance of the HLT Meridian TAVR system in treating aortic stenosis and aortic regurgitation among high-risk patients suffering from aortic disease.

FDA approves two clinical trials for HLT’s TAVR system

The company designed the HLT Meridian TAVR system to offer the benefits of both balloon-expandable and self-expanding platforms with a lower profile and non-obstructive design that reduces coronary and conduction obstruction, according to a news release.

HLT said the design aims to increase hemodynamic performance to reduce the concern of patient-prosthesis mismatch. The company added that the HLT Meridian TAVR system represents the only TAVR valve with an isolated valve structure where leaflets are not attached to an annular structure in an effort to reduce tissue stress, improve long-term durability, minimize leakage and minimize ventricular exposure.

“We are thrilled to be providing a minimally invasive option to patients suffering from aortic disease,” HLT President and CEO David R. Elizondo said in the release. “Currently, there are treatments available that focus specifically on aortic stenosis. The HLT technology has been designed to treat a much broader segment in aortic disease where current treatment options are limited.

“The HLT Meridian TAVR Valve System is designed to address both patients’ and physicians’ needs that are unmet by current offerings, and is intended to expand and optimize the clinical and procedural performance.”