The Maple Grove, MN-based company has won FDA approval for two clinical studies assessing the HLT Meridian TAVR Valve System.

Omar Ford

March 24, 2022

2 Min Read
Image Courtesy of Science Photo Library / Alamy Stock Photo

So far this year, there hasn’t been much noise in the transcatheter aortic valve replacement market. There certainly haven’t been groundbreaking developments in the space like there had been in 2021, which saw Abbott Laboratories winning FDA approval for a TAVR device and ending the duopoly held by Medtronic and Edwards Lifescience.

But there is some noise being made by HLT, a Bracco Group Company and a firm focused on TAVR therapy. The Maple Grove, MN-based won FDA approval for two clinical studies assessing the performance and safety of its HLT Meridian TAVR Valve System to treat aortic stenosis and aortic regurgitation among high-risk patients suffering from aortic disease.

HLT said it has the potential to stand out in the space because the valve its seeking approval for is different from current offerings on the market. TAVR options require multiple operators for deployment, do not allow for complete repositioning or assessment prior to implant and cannot treat expanded indications, such as aortic regurgitation.

Furthermore, the patients are left with concerning rates of adverse events such as the need for permanent pacemaker implantation, paravalvular leakage, and patient-prosthesis mismatch, all of which cause concern.

The company said unlike current TAVR solutions, the HLT Meridian TAVR Valve System is designed to have the benefits of both balloon expandable and self-expanding platforms with a lower profile and non-obstructive design that reduces coronary and conduction obstruction. Its design for increased hemodynamic performance is expected to reduce the concern of patient-prosthesis mismatch.

 "Currently, there are treatments available that focus specifically on aortic stenosis,” David Elizondo, President and CEO of HLT said in a release. “The HLT technology has been designed to treat a much broader segment in aortic disease where currently 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.”

HLT still has a lot of ground to cover before it hits the market – but if it does make it, the company will face off against some of the largest players in medtech.  Both Edwards and Medtronic have dominated the space for years having won the first approvals in the U.S. and Europe for TAVR systems. Marlborough, MA-based Boston Scientific was once a top contender in the space but lost momentum when it pulled the plug on its Lotus TAVR platform.

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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