FDA approves two clinical trials for HLT’s TAVR system

[Image from HLT’s website]HLT announced today that it received FDA approval for two clinical studies for its HLT Meridian transcatheter aortic valve replacement (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.

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 structu…

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