Tryton Medical, the leading developer of stents designed to treat bifurcation lesions, announced the completion of enrollment 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 IDE Trial, and has successfully enrolled 133 patients from Europe and the US.
"The completion of patient enrollment in the Extended Access Registry is a major milestone for Tryton Medical. We’re demonstrating power in numbers, now studying over 1,800 patients at more than 100 clinical sites across 15 countries,"said Shawn P. McCarthy, President and CEO of Tryton Medical.
The Tryton Extended Access Registry builds on the results of the TRYTON IDE Study, which showed the benefit of treatment with Tryton Side Branch Stent in a post-hoc analysis of patients involving significant bifurcations, representing the intended population.
In this intended population, the TRYTON IDE Study showed reductions in target vessel failure and statistical difference of side branch percent diameter stenosis in patients with side branch vessels of 2.25 mm diameter or greater by quantitative coronary angiography.
The Tryton Extended Access 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 Pivotal IDE Trial, will be submitted in a pre-market approval (PMA) application to the U.S. Food and Drug Administration before the end of 2015.
Tryton Side Branch Stent System is built using proprietary Tri-ZONE technology to offer a dedicated strategy for treating bifurcation lesions. Tryton’s cobalt chromium stent is deployed in the side branch artery using a standard single wire balloon-expandable stent delivery system. A conventional drug eluting stent is then placed in the main vessel.
Tryton Side Branch Stent has now been used to treat more than 11,000 patients worldwide. The Tryton Side Branch Stent is commercially available in multiple countries within Europe, Middle East & Africa, is investigational in the US, and is not available in Japan.