|[July 22, 2014]
Results of First-in-Human Study of Transcatheter Technologies' TAVI Device, TRINITY, Are Reported in EuroIntervention
REGENSBURG, Germany --(Business Wire)--
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
"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
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 CrimpingTM 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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