5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the
 Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV)
 surgery using Medtentia's MAR system in clinical investigation 2010-040 performed during June
 2011 - April 2016.
Inclusion Criteria:

 -  Signed Informed Consent Form.

 -  Subject had a successful MAR implantation in clinical investigation 2010-040.

 -  Subject is willing to participate in the follow-up study and to comply with the
 requirements of the Clinical Investigation Plan.

 Exclusion Criteria:

 -  Subjects who participated in the clinical investigation 2010-040 but had the MAR
 replaced with another mitral valve repair ring or system.