Transcatheter Technologies has announced that results of a first-in-human clinical study of its Trinity transcatheter aortic valve implantation (TAVI) system have been published ahead of print publication in the July issue of the peer-reviewed medical journal EuroIntervention (“Trinity heart valve prosthesis—a novel repositionable and retrievable transapical transcatheter aortic valve system”).
Principal investigator for the study was Christian Hengstenberg, a cardiologist at German Heart Centre, Munich. (The implantation of the device was performed in Caracas, Venezuela.) Hengstenberg’s patient was a 74-year-old female suffering from severe, symptomatic aortic stenosis. At six-month follow-up, her mean pressure gradient was reduced from 59mmHG at the start of the study to just 22mmHG at six months post-implantation. Equally important, there was no paravalvular leak and no atrio-ventricular block, which would have necessitated a pacemaker implantation.
“The Trinity aortic valve is designed to be positioned precisely or even repositioned after full implantation, in a safe and simple manner,” says Hengstenberg. “In our study, Trinity’s novel sealing cuff continues to provide outstanding follow-up results without paravalvular leak, which is a frequent complication of TAVI. Equally important, the Trinity aortic valve is designed to reduce the risk of atrio-ventricular block significantly through supra-annular positioning of the Trinity valve.”
“There are several self-expanding TAVI devices claiming repositionability during the implantation process,” says Wolfgang Goetz, chief executive officer, a cardiac surgeon by training. “The problem with these second-generation TAVI systems is that they cannot be truly repositioned once fully implanted. Trinity, on the other hand, is designed to solve this critically important issue and thereby potentially reduce the undesirable side consequences of paravalvular leak,” adds Goetz. “With Trinity, once our valve is completely expanded and anchored above the annulus, a cardiologist can fully evaluate the valve’s function to determine whether it needs to be repositioned, retrieved, or kept in the same position. This feature and its supra-annular anchoring are absolutely unique to Trinity, which is why we have positioned Trinity as a third-generation TAVI system.”