Paris-based HighLife’s latest trans-septal mitral valve replacement (TSMVR) is a large annulus valve (LAV). The company designed it to fit within its existing delivery catheter and to accommodate large annuli up to 53 mm. It expects the valve to significantly expand the patient population eligible for TSMVR and provide a much-needed treatment option.
HighLife said the first implants of the LAVs in the U.S. took place at Tucson Medical Center in Arizona. Dr. Thomas Waggoner, a structural interventional cardiologist there, performed the implant.
“We are proud to be the first center in the world to implant the LAV,” Waggoner said. “The outcome obtained is very positive with elimination of MR immediately post-procedure.”
Waggoner added that the hospital discharged the patient only one day after the procedure and received positive feedback since. He noted that the HighLife valve offers a “game-changer” for MR patients.
The company offers the valve in both its full-coverage and Clarity configurations for patients with left ventricular outflow tract obstruction. It remains under investigation in clinical studies in the U.S., France, Belgium, Germany and Australia. The company submitted it for inclusion in ongoing studies in other geographies, too.
“We are excited to launch the large annulus valve,” said Georg Börtlein, HighLife founder and CEO. “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 U.S.”
