Transcatheter Technologies Reports 6-Month Data for Pilot Study of Trinity TAVI System

March 18, 2014—Transcatheter Technologies GmbH (Regensburg, Germany) announced 6-month follow-up results for a pilot study of its Trinity transcatheter aortic valve implantation (TAVI) system. According to the company, the follow-up data showed that the mean pressure gradient was reduced from 59 mm Hg at the start of the study to 22 mm Hg at 6 months after implantation. Patients had no atrioventricular (AV) block or new pacemaker implantation and no paravalvular leak (PVL).

The study is being led by principal investigator Prof. Christian Hengstenberg, MD, a cardiologist at the German Heart Center in Munich, Germany. Prof. Hengstenberg has no financial interest or affiliation with Transcatheter Technologies, noted the company.

In the company’s press release, Prof. Hengstenberg commented, “No doubt, these 6-month clinical results are striking. 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 AV block has been mitigated due to the supra-annular positioning of the Trinity valve.”

Transcatheter Technologies stated that the Trinity is a third-generation TAVI system that is designed to be truly repositionable. The Trinity aortic valve prosthesis is comprised of a bovine pericardium valve with a porcine pericardium-sealing cuff that is mounted on a self-expanding nitinol frame. The Trinity device is premounted on a detachable catheter tip. The device enables controlled positioning and true repositioning without foreshortening. The valve prosthesis is protected during folding of the stent by means of the company’s Zero Pressure Crimping technology, which is expected to improve valve durability and broaden the application of transcatheter valve implantations across a larger patient population, the company stated.