Tryton Medical has announced the completion of enrolment in the Extended Access Registry, a single arm study of its Tryton side branch stent. The Tryton registry is designed to confirm the results from Tryton’s pivotal Investigational Device Exemption (IDE) trial, and has successfully enrolled 133 patients from Europe and the USA.
“The completion of patient enrolment in the Extended Access Registry is a major milestone for Tryton Medical. We are demonstrating power in numbers, now studying over 1,800 patients at more than 100 clinical sites across 15 countries. We have also generated extensive real world clinical experience with over 11,000 patients treated with Tryton thus far in countries where it is commercially available,” said Shawn P McCarthy, president and chief executive officer of Tryton Medical. “We are very grateful to our investigators and their research teams for their dedication to this important trial. We will soon be filing our pre-market approval application to the Food and Drug Administration (FDA), and remain on schedule to be the first and only dedicated bifurcation stent available in the USA.”
The Tryton Extended Access Registry builds on the results of the Tryon IDE study, which showed the benefit of treatment with Tryton stent in a post hoc analysis of patients involving significant bifurcations, representing the intended population. In this intended population, the study showed reductions in target vessel failure and statistical difference of side branch per cent diameter stenosis in patients with side branch vessels of 2.25mm diameter or greater by quantitative coronary angiography. The Tryton Registry is designed to further confirm the acceptable safety profile of the Tryton stent as seen in the post hoc analysis. Results from this registry, together with results from the IDE trial, will be submitted in a pre-market approval application to the FDA before the end of 2015.
Coronary artery disease often results in the build-up of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating bifurcation lesions can be time-consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. In addition, accumulation of plaque that narrows the base of the coronary tree (left main disease) remains a persistent challenge in interventional cardiology that could benefit from new treatment options. More than 75% of left main lesions are bifurcation lesions.