Valcare Medical has received approval from the US Food and Drug Administration (FDA) for its investigational device exemption (IDE) application concerning the AMEND Trans-Septal System.
The latest approval allows the company to initiate an Early Feasibility Study (EFS) to evaluate the device’s effectiveness.
The AMEND Trans-Septal System is a transcatheter device developed to treat mitral insufficiency. It incorporates a semi-rigid, closed, D-shaped annuloplasty ring designed to emulate the current surgical gold standard for mitral valve repair.
The upcoming EFS will assess the safety and effectiveness of the AMEND Trans-Septal System in patients experiencing symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) who meet the anatomical criteria for transcatheter mitral annuloplasty.
The study aims to recruit up to 15 participants across seven investigational sites in the US.
Patient enrolment is expected to begin in the first half of 2025, with plans for a pivotal study projected for 2027.
The trial will focus on various primary and secondary endpoints, including safety and device performance evaluations. Key performance indicators will include the successful delivery of the ring, implantation, and retrieval of the delivery system.
Furthermore, the study will track patient outcomes such as the incidence of stroke, myocardial infarction, non-elective cardiovascular surgeries due to device-related complications, and overall mortality rates at 30 days and six months following the procedure.
Additional secondary endpoints will measure changes in New York Heart Association (NYHA) functional class, results from the 6-Minute Walk Test, quality of life metrics at 30 days and six months, and a decrease in MR grade from baseline by at least one grade at 30 days, six months, and one year.
AMEND EFS study chairman and professor of Medicine & Pediatrics at the University of British Columbia, and professor Emeritus with Tenure at the University of Virginia Dr Scott Lim said: “The AMEND annuloplasty ring has the potential to improve mitral repair for a patient population that are considered poor candidates for currently available therapies.
“Furthermore, the AMEND System provides a non-invasive approach to the gold standard surgical repair, and I am excited for its potential to treat patients suffering from severe mitral regurgitation.”
Valcare Medical president and CEO 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.”
