HighLife Adds Large Annulus Valve to Investigational TSMVR System

September 6, 2023—HighLife SAS announced the introduction of a new valve size in its clinical trials. The company is developing a transseptal mitral valve replacement (TSMVR) system to treat patients with moderate to severe mitral regurgitation (MR). The new, large annulus valve (LAV) is designed for patients with larger anatomies.

According to the company, there has been a lack of treatment options for patients with large annuli. The new LAV is specifically designed to fit within HighLife’s existing delivery catheter and can accommodate large annuli up to 53 mm. The LAV is expected to significantly expand the patient population eligible for TSMVR and will provide a much-needed treatment option for physicians.

The LAV is constructed for both full-coverage and Clarity configurations. HighLife’s Clarity valves are specifically intended for patients with a risk for left ventricular outflow tract obstruction, noted the company.

HighLife, which is headquartered in Paris, France, with facilities in Irvine, California, is a precommercial stage company.

The company advised that the HighLife valves are investigational devices and not for sale in any geography. The TSMVR solution developed by HighLife consists of a valve-in-ring concept, both ring and valve being implanted percutaneously. The valve is deployed in a beating heart, reducing trauma to the patients. It is currently evaluated in clinical studies across three continents.

The LAV is under investigation in clinical studies in the United States, France, Belgium, Germany, and Australia and has been submitted for inclusion in ongoing studies in other geographies.

The first LAVs were implanted in the United States by structural interventional cardiologist Thomas Waggoner, DO, who is director of structural heart and director of cardiovascular research at Tucson Medical Center in Tucson, Arizona.

“We are proud to be the first center in the world to implant the LAV,” commented Dr. Waggoner in the company’s press release. “The outcome obtained is very positive with elimination of MR immediately postprocedure. The patient was discharged home only 1 day after the procedure and is doing very well since.”

Dr. Waggoner continued, “HighLife’s solution and this new valve size are a game-changer for our patients with MR. This aligns with our vision to improve the well-being and lives for all patients. We look forward to enroll and treat more patients in HighLife’s clinical study!”

Georg Börtlein, founder and chief executive officer of HighLife, added, “We are excited to launch the LAV. Addressing the unmet needs of patients with moderate to severe MR has been our focus and we are pleased to see that our efforts are enabling access to more patients in our clinical trials. This is an important milestone as we are preparing for our future pivotal study in the United States.”