Valcare Medical a has received approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the AMEND™ Trans-Septal System.
The AMEND™ Trans-Septal System is designed for the treatment of mitral insufficiency and features a semi-rigid, closed, D-shaped annuloplasty ring that replicates the current surgical standard.
The study will assess the safety and effectiveness of this transcatheter device in patients with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) who are considered suitable for transcatheter mitral annuloplasty.
Key measures of the study will include the technical success of ring delivery, implantation, and retrieval, alongside patient safety outcomes such as stroke, myocardial infarction, non-elective cardiovascular surgery due to device-related complications, and overall mortality at 30 days and six months after implantation.
Additional assessments will focus on improvements in patient condition, including changes in NYHA functional class, results from the 6-Minute Walk Test, and overall quality of life. The study will also measure the reduction in mitral regurgitation severity by at least one grade at 30 days, six months, and one year.
The approval marks an important step in Valcare Medical’s progress towards obtaining Pre-Market Approval in the United States.
