Rachel Klemovitch, Assistant Editor09.07.23
Meditech company, HighLife SAS, specializing in the development of a novel trans-septal mitral valve replacement (TSMVR) system for patients with moderate to severe mitral regurgitation (MR) introduced a new valve size to its clinical trials. The Large Annulus Valve (LAV) is designed for patents with larger anatomies.
“We are excited to launch the Large Annulus Valve, 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 on out clinical trials. This is an important milestone as we are preparing for our future pivotal study in the USA,” said founder and CEO Georg Börtein.
First LAVs were implemented in the USA. This new LAV accommodates large annuli up to 53 mm and is designed to fit into the company’s existing delivery catheter. The LAV is expected to expand the current patient population eligible for TSMVR proving treatment options to HighLife’s physician partners.
“We are proud to be the first center in the world to implant the LAV. The outcome obtained is very positive with the elimination of MR immediately post-procedure,” stated Dr. Thomas Waggoner at Tucson Medical Center, Ariz. “HighLife’s solution and this new valve size are game-changers for our patients with Mitral Regurgitation. This aligns with our vison to improve the well-being and live for all our patients. We look forward to enroll and treat more patients in HighLife’s clinical study.”
LAV is available in both Clarity and full-coverage configurations. Clarity valves are intended for patients with a risk of LVOT (left ventricular outflow tract) obstruction. The LAV is currently under investigation within clinical studies in USA, Belgium, Australia, Germany, and France with submission for inclusion in other countries.
“We are excited to launch the Large Annulus Valve, 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 on out clinical trials. This is an important milestone as we are preparing for our future pivotal study in the USA,” said founder and CEO Georg Börtein.
First LAVs were implemented in the USA. This new LAV accommodates large annuli up to 53 mm and is designed to fit into the company’s existing delivery catheter. The LAV is expected to expand the current patient population eligible for TSMVR proving treatment options to HighLife’s physician partners.
“We are proud to be the first center in the world to implant the LAV. The outcome obtained is very positive with the elimination of MR immediately post-procedure,” stated Dr. Thomas Waggoner at Tucson Medical Center, Ariz. “HighLife’s solution and this new valve size are game-changers for our patients with Mitral Regurgitation. This aligns with our vison to improve the well-being and live for all our patients. We look forward to enroll and treat more patients in HighLife’s clinical study.”
LAV is available in both Clarity and full-coverage configurations. Clarity valves are intended for patients with a risk of LVOT (left ventricular outflow tract) obstruction. The LAV is currently under investigation within clinical studies in USA, Belgium, Australia, Germany, and France with submission for inclusion in other countries.