The AMEND™ Trans-Septal System is a trans catheter device intended for treatment of mitral insufficiency with a semi rigid, closed, D-shaped annuloplasty ring that mimics today’s surgical gold standard.

The EFS study will evaluate the safety and functionality of the AMEND™ Trans-Septal System in the treatment of subjects with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) that are anatomically suitable for transcatheter mitral annuloplasty. The EFS will enroll up to 15 subjects in 7 investigational centers in the United States. The study is expected to begin treating patients in the first half of 2025, paving the way for a pivotal study anticipated in 2027.

The primary and secondary endpoints of this trial include safety and device performance assessments such as technical success of ring delivery, implantation, and delivery system retrieval. Patient outcomes such as stroke, myocardial infarction, non-elective cardiovascular surgery for device related complications, and all-cause mortality are to be reported at 30 days and 6 months post implantation.

Additional secondary endpoints will include changes in NYHA functional class, 6-Minute-Walk-Test, quality of life at 30 days and 6 months in addition to reduction of MR grade from baseline by at least 1 grade at 30 days, 6 months and 1 year.