REGENSBURG, Germany--(BUSINESS WIRE)--Transcatheter Technologies GmbH, an emerging medical device company that is developing a third-generation transcatheter aortic valve implantation (TAVI) system—Trinity—announced today the successful 30-day 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 TAVI system.
The pilot study included four female patients, mean age of 71 years. At 30 days follow-up, the mean pressure gradient was reduced from 59 mmHG at the start of the study to just 20 mmHG at 30 days post-implantation. All patients had zero AV-block or new pacemaker, and zero paravalvular leak (PVL).
“Certainly, these early clinical results are very impressive,” said principal investigator Prof. Dr. Christian Hengstenberg. A cardiologist at the German Heart Center, Munich, Germany, Prof. Dr. Hengstenberg has no financial interest or arrangement or affiliation with Transcatheter Technologies. “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 PVL, which is a frequent complication of TAVI(1). Equally critical, the risk of atrio-ventricular (AV) block is dramatically reduced due to the supra-annular positioning of the Trinity valve.”
“A severe limitation of the second-generation TAVI systems is that they cannot be truly repositioned once fully implanted. Trinity, however, is designed to solve this substantial issue and therein potentially reduces the undesirable side consequences of PVL and AV block,” said Wolfgang Goetz, M.D., Ph.D., CEO, a cardiac surgeon by training. “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 is 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 CrimpingTM is expected to improve valve durability and broaden the application of transcatheter valve implantations across a larger patient population.
(1) J Am Coll Cardiol. 2013 Mar 19;61(11):1125-36. doi: 10.1016/j.jacc.2012.08.1039. Epub 2013 Jan 30. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles' heel? A comprehensive review of the literature. Généreux P, Head SJ, Hahn R, Daneault B, Kodali S, Williams MR, van Mieghem NM, Alu MC, Serruys PW, Kappetein AP, Leon MB.
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