Tryton Medical has recruited first patient in E-Tryton Italy, a registry study of the company’s Side Branch Stent System.
E-Tryton Italy is one of four registries in Europe evaluating the Tryton Side Branch Stent System in real-world clinical settings.
Tryton Medical claims that its Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation.
The E-Tryton Italy registry is expected to recruit at least 300 patients at several sites throughout Italy.
The primary endpoint of the study is the overall rate of major adverse cardiac events (MACE) at six months following the procedure.
The study will also investigate the technical success of the Tryton stent, procedural success, and the rate of target lesion revascularization (TLR) at six months after the procedure.
In addition, the study will include an angiographic and optical coherence technology (OCT) follow-up subgroup.
Principal investigator of the study Marco Valgimigli said that data from the Tryton Side Branch Stent System has been highly promising, and they hope to continue to confirm these excellent results in patients with bifurcation disease in real-world hospital settings in Italy
Tryton Medical president and CEO Greg Davis said that with more than 2,000 patients treated to date, they have received highly positive feedback from physicians on the system’s deliverability and ease of use.