Transcatheter Technologies has revealed the successful 30-day follow-up results from a pilot study of its “truly prepositional” transcatheter aortic valve implantation (TAVI) system Trinity. The results show that the system is associated with a reduction in mean pressure gradient from 59mmHg at baseline to 20mmHG at 30 days post-implantation.
According to a press release, at 30 days, no patients had atrioventricular block, none required a new pacemaker, and none had paravalvular leak.
Principal investigator Christian Hengstenberg (German Heart Center, Munich, Germany), says: “Certainly, these early clinical results are very impressive. Unlike second-generation TAVI systems, the Trinity aortic valve [a third-generation device] was able to be positioned precisely or repositioned, even after full implantation, in a safe manner. In our study, Trinity’s novel sealing cuff is providing excellent results without paravalvular leak. Equally critical, the risk of atrio-ventricular block was dramatically reduced due to the supra-annular positioning of the Trinity valve.”
The press release reports that the Trinity aortic valve prosthesis is comprised of a bovine pericardium valve with porcine pericardium-sealing cuff that is mounted on a self-expanding nitinol frame. The valve is pre-mounted on a detachable catheter tip.