German device company Transcatheter Technologies GmbH, has announced the successful 6-month 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 (so says the company’s press release) TAVI system.
Background
Second generation TAVI offerings are increasingly claiming repositionability, a feature not present in first generation offerings. The theory goes that by being able to re-sheath the valve following initial deployment, the physician can optimise its location and minimise paravalvular leakage that plagued initial attempts to insert valves using minimal access approaches.
One company claiming superior repositionability is German company, Transcatheter Technologies GmbH with its Trinity aortic valve prosthesis. Trinity is comprised of a bovine pericardium valve with porcine pericardium-sealing cuff that is mounted on a self-expanding Nitinol frame. The Trinity aortic valve prosthesis is pre-mounted on a detachable catheter tip and offers controlled positioning and true repositioning without foreshortening. On top of that, the company incorporates what it calls Zero Pressure CrimpingTM in its device, an approach that protects the stent during folding and is expected to improve valve durability.
In a newly published study, 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 (PVL).
Investigator comments
“No doubt, these six-month clinical results are striking,” said principal investigator Prof. Dr. Christian Hengstenberg. A cardiologist at the German Heart Center, Munich, Germany, Prof. Dr. 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 PVL, which is an unacceptably frequent complication of TAVI. Equally important, the risk of atrio-ventricular (AV) block has been mitigated due to the supra-annular positioning of the Trinity valve.”
Company comments
“A severe limitation of currently marketed TAVI systems is that they cannot be repositioned once fully implanted. On the other hand, Trinity is designed to solve this life-threatening issue and thereby potentially reduces the unwanted consequences of PVL and AV block,” said Wolfgang Goetz, M.D., Ph.D., CEO, a cardiac surgeon by training. “Once our Trinity valve is completely expanded and anchored above the annulus, a cardiologist can then fully assess 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.”
Source: Transcatheter Technologies GmbH
published: March 19, 2014 in: Cardio, Clinical Studies/Trials