HighLife SAS has announced that the US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to initiate a US pivotal study evaluating its transseptal mitral valve replacement (TSMVR) technology.
The pivotal study is a single-arm, multicentre, prospective study assessing the safety and effectiveness of the HighLife TSMVR system in patients with moderate to severe functional mitral regurgitation (FMR), unsuitable for surgery or transcatheter repair treatment. This patient population lacks approved therapeutic options, leading to a poor prognosis with many recurrent hospitalisations and reduced life expectancy.
The pivotal study is expected to enrol patients at clinical sites in the USA, Europe and Asia–Pacific (APAC). Over 100 patients have been treated with the HighLife technology within different clinical programs in the USA, Europe and APAC. Study results have been presented at conferences globally and published in JACC: Cardiovascular Interventions.
Gregg W Stone (Icahn School of Medicine at Mount Sinai, New York, USA) will be the principal investigator of the pivotal study.
“I am honoured to lead the HighLife pivotal study,” said Stone. “There is still a significant unmet clinical need for patients suffering from mitral regurgitation and TMVR is a promising treatment option. 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.”
Georg Börtlein, founder and chief executive officer of HighLife, said: “We are extremely pleased with the FDA IDE approval for our US pivotal study, marking a significant milestone in our US clinical strategy. This approval aligns with the maturity of our extensive clinical dataset generated over multiple sites across three continents. We are also making great progress towards CE mark readiness, eagerly anticipating the market introduction of our technology in Europe.”
