Thirty-Day Results Reported From Pilot Study of Transcatheter Technologies' Trinity TAVI System

November 26, 2013—Transcatheter Technologies GmbH (Regensburg, Germany) announced the 30-day follow-up results for a pilot study of its Trinity device, which the company stated is a “third-generation” transcatheter aortic valve implantation (TAVI) system that is designed to be “truly repositionable.” With the Trinity TAVI system, when the valve is completely expanded and anchored above the annulus, the interventional cardiologist can fully evaluate the valve's function to determine whether it needs to be repositioned, retrieved, or kept in the same position, stated the company.

According to the company, the pilot study included four female patients (mean age, 71 years). The mean pressure gradient was reduced from 59 mm Hg at the start of the study to 20 mm Hg at 30 days after implantation. There was no reported atrioventricular block, no new pacemaker implantation, and no paravalvular leak.

“Certainly, these early clinical results are very impressive,” commented principal investigator Prof. Christian Hengstenberg, MD, in the company's press release. Prof. Hengstenberg is a cardiologist at the German Heart Center in Munich, Germany. He continued, “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 paravalvular leak, which is a frequent complication of TAVI. Equally critical, the risk of atrioventricular block is dramatically reduced due to the supra-annular positioning of the Trinity valve.”

The Trinity aortic valve prosthesis is composed of a bovine pericardium valve with a porcine pericardium-sealing cuff that is mounted on a self-expanding nitinol frame. The prosthesis is premounted on a detachable catheter tip. The device is designed to enable controlled positioning and true repositioning without foreshortening. The valve prosthesis is protected during folding of the stent. The company's Zero Pressure Crimping technology is expected to improve valve durability and broaden the application of TAVI across a larger patient population, stated Transcatheter Technologies.