Transcatheter Technologies announced the successful six-month follow-up results for a pilot study of its Trinity TAVI system that is designed to be the world’s first ‘truly repositionable’ transcatheter aortic valve implantation (TAVI) system.
According to the company report, at six-month follow-up, the mean pressure gradient was reduced from 59 mmHG at the start of the study to just 22 mmHG at six months post-implantation. Patients had zero AV-block or new pacemaker, and zero paravalvular leak.
“No doubt, these six-month clinical results are striking,” says principal investigator Christian Hengstenberg. A cardiologist at the German Heart Center, Munich, Germany, Hengstenberg has no financial interest or affiliation with Transcatheter Technologies. “Unlike the second-generation TAVI systems, the Trinity aortic valve is able to be positioned precisely or in fact repositioned, even after full implantation, in a safe manner. In our study, Trinity’s novel sealing cuff continues to provide outstanding results without paravalvular leak, which is an unacceptably frequent complication of TAVI. Equally important, the risk of atrio-ventricular block has been mitigated due to the supra-annular positioning of the Trinity valve.”