Sam Brusco, Associate Editor06.03.24
HighLife Medical has been granted an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a pivotal study of its novel transseptal mitral valve replacement (TSMVR) system to treat moderate to severe mitral regurgitation (MR).
The single-arm, multicenter, prospective study will assess the HighLife TSMVR’s safety and effectiveness to treat patients with moderate to severe functional MR who are unsuitable for surgery or transcatheter repair. This population of patients lacks approved therapeutic options.
HighLife’s TSMVR consists of a valve-in-ring concept with both ring and valve implanted percutaneously. The valve is deployed in a beating heart to reduce trauma to patients.
The pivotal study aims to enroll patients at clinical sites in the U.S., Europe, and APAC. It is currently evaluated in clinical studies across three continents, according to the company.
Prof. Gregg W. Stone, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai will be the Principal Investigator of the pivotal study.
“I am honored to lead the HighLife pivotal study. 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,” commented Prof. Stone.
Georg Börtlein, founder and CEO of HighLife, added, “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.”
The single-arm, multicenter, prospective study will assess the HighLife TSMVR’s safety and effectiveness to treat patients with moderate to severe functional MR who are unsuitable for surgery or transcatheter repair. This population of patients lacks approved therapeutic options.
HighLife’s TSMVR consists of a valve-in-ring concept with both ring and valve implanted percutaneously. The valve is deployed in a beating heart to reduce trauma to patients.
The pivotal study aims to enroll patients at clinical sites in the U.S., Europe, and APAC. It is currently evaluated in clinical studies across three continents, according to the company.
Prof. Gregg W. Stone, Director of Academic Affairs for the Mount Sinai Health System and Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai will be the Principal Investigator of the pivotal study.
“I am honored to lead the HighLife pivotal study. 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,” commented Prof. Stone.
Georg Börtlein, founder and CEO of HighLife, added, “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.”