Transcatheter Technologies has announced the successful 30-day follow-up results for a pilot study of its Trinity TAVI system that is designed to be the world’s first ‘truly repositionable’ and, therefore, best TAVI system.
The pilot study included four female patients, mean age of 71 years. At 30 days follow-up, the mean pressure gradient was reduced from 59mmHG at the start of the study to just 20mmHG at 30 days post-implantation. All patients had zero AV-block or new pacemaker, and zero paravalvular leak (PVL).
“Certainly, these early clinical results are very impressive,” said principal investigator Prof. Dr. Christian Hengstenberg. A cardiologist at the German Heart Center, Munich, Germany, Prof. Dr. Hengstenberg has no financial interest or arrangement or affiliation with Transcatheter Technologies. “Unlike second-generation TAVI systems, the Trinity aortic valve 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 PVL, which is a frequent complication of TAVI.(1) Equally critical, the risk of atrio-ventricular (AV) block is dramatically reduced due to the supra-annular positioning of the Trinity valve.”
“A severe limitation of the second-generation TAVI systems is that they cannot be truly repositioned once fully implanted. Trinity, however, is designed to solve this substantial issue and therein potentially reduces the undesirable side consequences of PVL and AV block,” said Wolfgang Goetz, MD, PhD, CEO, a cardiac surgeon by training. “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 is absolutely unique to Trinity, which is why we have positioned Trinity as a Third-Generation TAVI System.”
- Généreux P et al. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles’ heel? A comprehensive review of the literature. J Am Coll Cardiol 2013;61(11):1125-36.