United States Enrollment Begins in Early Feasibility Study of HLT's TAVR System

June 6, 2017—HLT, Inc. announced that the first United States procedures were performed in the early feasibility RADIANT clinical study. The RADIANT trial seeks to assess the safety and performance outcomes of HLT's Meridian transcatheter aortic valve replacement (TAVR) device and the Pathfinder II delivery system in patients with severe aortic stenosis who are at high risk for surgery. The device is approved for investigational use only and is not available for sale in any market, advised the company.

RADIANT is a prospective, nonrandomized, single-arm, multicenter study that will enroll up to 20 high-risk patients with severe aortic valve stenosis. The primary safety endpoint will evaluate all-cause mortality at 30 days. Patient follow-up will occur at 1, 6, and 12 months and then annually to 5 years.

The initial procedures were completed by RADIANT's United States Principal Investigator Mathew R. Williams, MD, at New York University's Langone Medical Center in New York, New York, where Dr. Williams is Associate Professor of Cardiothoracic Surgery, Director of the Heart Valve Center, Chief of Adult Cardiac Surgery, and Director of Interventional Cardiology.

In the company's announcement, Dr. Williams commented, "The HLT TAVR design enables us to fully assess valve function prior to releasing the valve in the heart, reposition it to achieve optimal performance prior to final release, or retrieve it if necessary. As a result, our first procedure with the Meridian valve could be performed quickly and easily. In addition, the level of control that the system provides enabled us to perform the procedure under conscious sedation rather than general anesthesia."

According to HLT, the Meridian transcatheter aortic valve is designed to conform to the natural structure of the heart. The Pathfinder II delivery system provides physicians control over valve placement in a beating heart, as well as flexibility to reposition or fully retrieve the valve before release. The Meridian valve is composed of a flexible wire frame that supports the leaflets and a shorter height with minimal extension into the left ventricle, noted Robert Wilson, MD, who is HLT's Founder and Chief Scientific and Innovation Officer.

HLT is a privately held clinical-stage company headquartered in Maple Grove, Minnesota. HLT and its sister company, Acist Medical Systems Inc., are part of the Bracco Group, which is based in Milan, Italy.