HighLife SAS has announced the introduction of a new valve size in its clinical trials of a transseptal mitral valve replacement (TSMVR) for the treatment of moderate to severe mitral regurgitation (MR), the large annulus valve (LAV), designed for patients with larger anatomies.
Among patients with moderate to severe MR, there has been a lack of treatment options for patients with large annuli, the company said in a press release. The new LAV is specifically designed to fit within HighLife’s existing delivery catheter and can accommodate large annuli up to 53mm. The
The first LAVs were implanted in the USA. “We are proud to be the first center in the world to implant the LAV,” said Thomas Waggoner (Tucson Medical Center, Tucson, USA). “The outcome obtained is very positive with elimination of MR immediately post-procedure. The patient was discharged home only one day after the procedure and is doing very well since.
“HighLife’s solution and this new valve size are a game-changer for our patients with mitral regurgitation. This aligns with our vision to improve the wellbeing and lives for all patients. We look forward to enrol and treat more patients in HighLife’s clinical study.”
“We are excited to launch the large annulus valve,” adds Georg Börtlein, founder and chief executive officer of HighLife. ”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 USA.”
The LAV is available in both the full-coverage and Clarity configurations. HighLife’s Clarity valves are specifically intended for patients with a risk for left ventricular outflow tract (LVOT) obstruction. The LAV is under investigation in clinical studies in the USA, France, Belgium, Germany and Australia and has been submitted for inclusion in ongoing studies in other geographies.