HighLife to Initiate United States Pivotal Study of TSMVR System

June 3, 2024—HighLife SAS, a France-based developer of a transseptal mitral valve replacement (TSMVR) system to treat patients with moderate-to-severe mitral regurgitation (MR), announced that the FDA granted an investigational device exemption (IDE) to initiate a United States pivotal study with its technology.

According to the company, the single-arm, multicenter, prospective pivotal study will assess the safety and effectiveness of the HighLife TSMVR system in patients with moderate-to-severe functional MR unsuitable for surgery or transcatheter repair treatment. The pivotal study is expected to enroll patients at clinical sites in the United States, Europe, and the Asia-Pacific region.

The principal investigator of the pivotal study will be Professor Gregg W. Stone, MD. Dr. Stone is Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai in New York, New York.

“I am honored to lead the HighLife pivotal study,” commented Prof. Stone in the company’s press release. “There is still a significant unmet clinical need for patients suffering from MR and TMVR is a promising treatment option.”

Prof. Stone continued, “The HighLife TMVR solution offers the potential to provide important clinical benefits for these high-risk patients. We are gratified that FDA has granted approval for this pivotal study that will further advance the management of patients with MR.”

The TSMVR solution developed by HighLife consists of a valve-in-ring concept. Both the ring and valve are implanted percutaneously in a three-step procedure. HighLife valves are investigational devices and not for sale in any geography, advised the company.

The company noted that more than 100 patients have been treated with the HighLife technology within different clinical programs in the United States, Europe, and Asia-Pacific region with study results presented at conferences globally.

In December 2023, HighLife announced the publication of the 1-year findings from the HighLife TSMVR feasibility study by Leonhard-Moritz Schneider, MD, et al in JACC: Cardiovascular Interventions (2023;16:2854–2865). An accompanying editorial commentary by Nicole Karam, MD, and Lukas Stolz, MD, was published in JACC: Cardiovascular Interventions (2023;16:2866-2877). The outcomes of the study’s first 30 patients assessed during 1 year of follow-up demonstrated a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention, stated the company.