Enrollment Completed in the Extended Access Registry for the Tryton Side Branch Stent

August 3, 2015—Tryton Medical, Inc. 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 the TRYTON pivotal investigational device exemption (IDE) trial. The Extended Access Registry has enrolled 133 patients from Europe and the United States.

According to the company, the Tryton Extended Access Registry builds on the results of the TRYTON IDE study, which showed the benefit of treatment with the 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 a statistical difference of side branch percent diameter stenosis in patients with side branch vessels ≥ 2.25 mm in diameter 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 premarket approval application to the US Food and Drug Administration before the end of 2015.

The Tryton side branch stent system features the company’s Tri-Zone technology for treating bifurcation lesions with Tryton’s cobalt chromium stent, which 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. The Tryton side branch stent is commercially available in multiple countries in Europe, the Middle East, and Africa. It is available for investigational use only in the United States, and it is not available in Japan, advised the company.