Article title: Transcatheter Annuloplasty for Mitral Regurgitation with an Adjustable Semi-Rigid Complete Ring: Initial Experience with the Millipede IRIS Device
Authors: Jason H. Rogers, MD, Walter D. Boyd, MD, Thomas W. R. Smith, MD, Adrian A. Ebner, MD, Eberhard Grube, MD, and Steven F. Bolling, MD
Journal: Structural Heart
Bibliometrics: Volume 2, Number 1, pages 43–50
DOI: https://doi.org/10.1080/24748706.2017.1385879
Consent information was not noted in the published article.
The following text was added to the Materials and Methods section:
For this study, the sponsor (Millipede) did submit to the IRB and received their written approval prior to initiating any study related activities. These implants were performed in Asuncion, Paraguay. In addition, the IRB reviewed and approved the patient Informed Consent Form which included consent to publish data. The Informed Consent Form was reviewed with all patients by the Site PI pre procedure. All patients signed the Informed Consent Form prior to the procedure, which was countersigned by the site PI. A third-party Clinical Research Organization performed a 100% audit of the process and the related case report forms and Informed Consent Form.