Tryton Medical, Inc. announced the enrollment of the first patient in E-Tryton 150 registry study. The E-Tryton 150 trial is evaluating Tryton Side Branch Stent System in real-world clinical settings. It is one of four registries in Europe.
The Tryton Side Branch Stent is used for treating atherosclerotic lesions at the site of a bifurcation. The Bifurcation lesions present significant limitations in current treatment approach. 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.
“I am thrilled to participate in E-Tryton 150,” said Dr. Eulogio Garcia. “Early data for the Tryton Side Branch Stent System is very promising, and we hope to confirm these excellent results in patients with bifurcation disease in real-world hospital settings. The Tryton Stent is easy to use and we are happy to start using it in our daily clinical practice.”
Several European sites will enroll 150 patients in E-Tryton 150 registry. The overall rate of major adverse cardiac events (MACE) at six months following the procedure will be primary endpoint of the study. The study will also assess the technical success of the Tryton stent, procedural success, and the rate of target lesion revascularization (TLR) at six months after the procedure.
“We’re very pleased to begin enrollment in E-Tryton,” said J. Greg Davis, president and CEO of Tryton Medical. “We are excited about the benefits that our technology promises for patients with cardiovascular disease, and we look forward to real-life practice results of the study.”