The US Food and Drug Administration (FDA) has granted approval for Valcare Medical’s investigational device exemption application, allowing it to begin an early feasibility study of its transcatheter device, the Amend Trans-Septal System, designed for the treatment of mitral insufficiency.
Amend features a closed, semi-rigid, D-shaped annuloplasty ring that is said to “mimic” the current surgical gold standard.
The study will assess the functionality and safety of the device in treating individuals with symptomatic moderate-to-severe or severe functional mitral regurgitation (FMR) who are eligible for transcatheter mitral annuloplasty.
It aims to enrol up to 15 subjects across seven investigational US centres, with subject treatment expected to start in the first half of this year, allowing for a pivotal trial anticipated in 2027.
The primary and secondary endpoints will focus on the safety of the device, including the technical achievement in delivering the ring, implantation, as well as delivery system retrieval.
According to the company, subject outcomes like myocardial infarction, stroke, all-cause death and non-elective cardiovascular surgery for complications associated with the device are set to be reported at 30 days and six months after the implantation.
The study will also measure secondary endpoints such as changes in the New York Heart Association functional class, six-minute walk test, as well as quality of life.
Additionally, it will evaluate the decrease of mitral regurgitation (MR) grade from baseline by a minimum of one grade at 30 days, six months and a year.
Valcare noted that, currently, the device holds US federal law limitation to be used solely for investigational purposes and is not intended to be commercially distributed or sold.
Valcare Medical CEO and president Steve Sandweg said: “The FDA’s approval to begin the Amend EFS is a critical milestone for Valcare Medical on the path to achieving eventual pre-market approval in the US.
“This study will build upon clinical data from the Amend First-in-Human Study, which will be presented as a Late Breaker Clinical Trial during this year’s CRT Conference in Washington DC next month.”
Valcare Medical is focused on developing minimally invasive solutions, aiming for the elimination of the open-heart surgery requirement in individuals with severe MR.
