Valvular & structural heart diseaseCohort study
Transeptal Mitral Annuloplasty With the AMEND System: 6-Month Results of First in Man Cohort
- First in Man Cohort
- multicenter
- 2 studies in Georgia and Israel
- compassionate approvals in Portugal and France
Authors' conclusion
In this small multicenter cohort of patients, the AMEND annuloplasty procedure demonstrated promising safety, with stable and significant reduction of MR maintained over the 6-month follow-up period.
Study context
- Population
- Patients with grade 3 or 4 functional mitral regurgitation (MR) undergoing transeptal mitral repair with the AMEND annuloplastypatients treated
- Participants
- Thirteen patients
Main finding
As reported in the abstract
MR grade · 6 months
patients with ≤grade 1 MR
11 of 13
Observational data: associations, not effects.
Safety
Deaths, myocardial infarctions, strokes or cardiac surgery
- None
Pericardial effusions
- pericardial effusions
- 2
- acute
- 1
- second at 4 months
Anchor disengagement or device dehiscence · over the follow-up period
- None
Readmission with heart failure
- single patient readmitted with heart failure; iatrogenic atrial septal defect was closed
Original publication
Transeptal Mitral Annuloplasty With the AMEND System: 6-Month Results of First in Man Cohort. Circ Cardiovasc Interv. Published 9 April 2026. doi:10.1161/circinterventions.125.015977
Summarised from the published abstract; every number is checked against it