DURHAM, N.C.--(BUSINESS WIRE)--Tryton Medical, Inc., the leading developer of stents to treat bifurcation lesions, today announced that results from the company’s pivotal clinical trial for the Tryton Side Branch Stent were published in the Journal of the American College of Cardiology. The Tryton Pivotal IDE Trial, which enrolled 704 patients at 67 centers in North America and in 11 countries in the EU and Israel, was the largest coronary bifurcation study ever conducted.
The Tryton Pivotal IDE trial was a randomized study comparing the Tryton Side Branch Stent to conventional provisional treatment with balloon angioplasty in the side branch. Both study groups were treated with standard drug eluting stents in the main vessel. Among the 704 patients in the study, fully 60 percent of side-branch vessels treated were smaller than 2.25 mm diameter by QCA. The intended population for the trial included patients presenting with side branch vessels of 2.25mm diameter or greater by QCA.
In an article entitled “A Randomized Trial of a Dedicated Bifurcation Stent Versus Provisional Stenting in the Treatment of Coronary Bifurcation Lesions," researchers reported that while the study did not meet its primary endpoint of non-inferiority in measures of target vessel failure (TVF) in the overall population of patients treated, post-hoc analysis of outcomes in the intended study population of 289 patients with side branch vessels of 2.25 mm diameter or greater by QCA showed reductions in TVF and side branch percent diameter stenosis with the Tryton stent. In addition, both the Tryton and provisional treatment strategies were shown to have similarly low rates of stent thrombosis and no cardiac deaths reported at nine months.
“The Tryon IDE Study is a landmark clinical trial representing the coordinated efforts of leading investigators in the U.S. and Europe,” stated Philippe Genereux, M.D., director of the Core Angiographic Laboratories at the Cardiovascular Research Foundation and the lead author of the manuscript. “The most important finding was the performance of the Tryton Stent in the intended population presenting with complex bifurcations involving significant side branches. In this population, Tryton showed a reduction of TVF within the non-inferiority margin pre-specified for the entire population and significantly reduced side branch percent diameter stenosis.”
“As we reported in October 2014, analysis of the findings from the Pivotal IDE Trial for Tryton Side Branch Stent indicates significant benefit in the intended treatment population. Based on these important findings, Tryton has initiated The Tryton Extended Access Registry, a single arm study of the Tryton Side Branch Stent designed to confirm results from the Pivotal IDE Trial in the intended treatment population of patients with lesions involving significant side bifurcation,” said Shawn P. McCarthy, president and CEO of Tryton Medical. “We remain on schedule to complete enrollment and file our pre-market approval application with the FDA this year.”
Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current treatment options are 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 patients undergoing PCI-stenting, approximately one-third have a bifurcation lesion. Left main disease, an accumulation of plaque that narrows the base of the coronary tree, is a persistent challenge in interventional cardiology, as more than 75 percent of left main lesions are bifurcation lesions
About the Tryton Side Branch Stent System
The Tryton Side Branch Stent System is built for bifurcation 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. The Tryton Side Branch Stent is commercially available in multiple countries in the EU, Middle East and Asia, and is investigational in the U.S.
About Tryton Medical, Inc.
Tryton Medical, Inc., located in Durham, N.C., is the leading developer of novel stent systems for the treatment of bifurcation lesions. For more information please visit www.trytonmedical.com and follow the company on Twitter at @TrytonMedical1.