Transcatheter Technologies, a emerging medical device company that is developing a next-generation transcatheter aortic heart valve prosthesis, announced the successful first-in-human implantation of its transapical TRINITY aortic valve designed to be the world’s best repositionable heart valve.
Transcatheter Technologies CEO and cardiac surgeon by training Dr Wolfgang Goetz said a major limitation of existing transcatheter aortic heart valves is that they cannot be repositioned once implanted. Trinity, however, is designed to solve this difficult problem.
"With Trinity, once our valve is initially placed, a cardiologist can fully evaluate the valve’s function to determine whether it needs to be repositioned, retrieved, or kept in the same position.
"Equally important, Trinity provides for a controlled positioning by allowing a cardiologist to slowly open the valve stent, thus improving the likelihood of a first-attempt correct placement," Goetz added.
German Heart Center in Munich cardiologist Christian Hengstenberg said the TRINITY aortic valve can be positioned precisely.
"Yet, it also allows for safe repositioning of the valve prosthesis — or even full retrieval — if necessary. Its unique sealing cuff provides excellent results without paravalvular leakage.
"Moreover, the risk for atrio-ventricular block is dramatically reduced due to the supraannular positioning of TRINITY," Hengstenberg added.
The results of the first-in-human clinical trial using Trinity will be presented at the annual TCT Meeting in San Francisco on Monday, October 28, 2013.