Transcatheter Technologies has announced that an independent laboratory has completed ‘advanced wear testing’ (AWT) of the company’s Trinity valve prosthesis, far exceeding minimum testing standards.
Indeed, AWT of the Trinity heart valve has already completed 600 million cycles, or an estimated 15 years of durability testing.
Transcatheter Technologies has previously announced the successful 30-day follow-up results of a pilot study of its Trinity transcatheter aortic-valve implantation (TAVI) system that is designed to be the world’s first ‘truly repositionable’ and, therefore, best TAVI system.
Transcatheter Technologies CEO Dr Wolfgang Goetz noted the company is extremely pleased that its Trinity valve has already demonstrated three times the minimum standard for advanced wear testing of a tissue heart valve.
"We also are extremely pleased with the continuing excellent results of our third-generation Trinity System in the follow-up of our first patient.
"The big issue with the second-generation TAVI systems is that they cannot be truly repositioned once fully implanted. Trinity, however, is designed to solve this critically important issue and thereby potentially reduce the undesirable side consequences of PVL.
"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," Goetz added.