German device maker Transcatheter Technologies GmbH said it finished durability-testing Trinity transcatheter aortic valve implantation system.
The company expects Trinity to be “the world’s 1st ‘truly repositionable'” replacement aortic valve. The device was put through 600 million cycles, or around 15 years, of durability testing by an independent lab, which reported that the device far exceeded minimum standards, according to a press release.
“We are extremely pleased that our Trinity valve has already demonstrated 3 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,” CEO and cardiac surgeon by training Dr. Wolfgang Goetz said in prepared remarks.
“The big issue with the 2nd-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,” 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.”
The Regensburg, Germany-based company released an early look at clinical results for its 3rd-generation Trinity transcatheter aortic valve implantation platform. The pilot results included 4 female patients, all of whom had no paravalvular leak at 30 days and no need for new pacemakers. The device is still not approved for use in the U.S.