[July 22, 2014]

Results of First-in-Human Study of Transcatheter Technologies' TAVI Device, TRINITY, Are Reported in EuroIntervention

Transcatheter Technologies GmbH, an emerging medical device company that is developing a third-generation transcatheter aortic valve implantation (TAVI) system-TRINITY-announced today that results of a first-in-human clinical study of its TRINITY system have been published ahead of print publication in the July issue of the peer-reviewed medical journal EuroIntervention ("TRINITY heart valve prosthesis-a novel repositionable and retrievable transapical transcatheter aortic valve system").

Principal investigator for the study was Prof. Dr. Christian Hengstenberg, a cardiologist at German Heart Centre, Munich. (The implantation of the device was performed in Caracas, Venezuela.) Prof. Dr. Hengstenberg's patient was a 74-year-old female suffering from severe, symptomatic aortic stenosis. At six-monthfollow-up, her mean pressure gradient was reduced from 59 mmHG at the start of the study to just 22 mmHG at six months post-implantation. Equally important, there was no paravalvular leak (PVL) and no atrio-ventricular (AV) block, which would have necessitated a pacemaker implantation.

"The Trinity aortic valve is designed to be positioned precisely or even repositioned after full implantation, in a safe and simple manner," said Prof. Dr. Hengstenberg. "In our study, Trinity's novel sealing cuff continues to provide outstanding follow-up results without PVL, which is a frequent complication of TAVI. Equally important, the TRINITY aortic valve is designed to reduce the risk of atrio-ventricular (AV) block significantly through supra-annular positioning of the TRINITY valve."

"There are several self-expanding TAVI devices claiming repositionability during the implantation process," said Wolfgang Goetz, M.D., Ph.D., CEO, a cardiac surgeon by training. "The problem with these second-generation TAVI systems is that they cannot be truly repositioned once fully implanted. TRINITY, on the other hand, is designed to solve this critically important issue and thereby potentially reduce the undesirable side consequences of PVL," added Dr. Goetz. "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 and its supra-annular anchoring are absolutely unique to TRINITY, which is why we have positioned TRINITY as a Third-Generation TAVI System."

About Transcatheter Technologies GmbH
Transcatheter Technologies GmbH is a privately held medical device company founded in 2009 and headquartered in Regensburg, Germany. 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 TRINITY aortic valve prosthesis is pre-mounted on a detachable catheter tip. TRINITY's unique features enable controlled positioning and true repositioning without foreshortening. The valve prosthesis is protected during folding of the stent. This Zero Pressure Crimping^TM is expected to improve valve durability and broaden the application of transcatheter valve implantations across a larger patient population.

CAUTION: TRINITY is not approved for use in the United States.

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