E-Tryton 150 Registry Begins

June 30, 2009—Tryton Medical, Inc. (Durham, NC) announced enrollment of the first patient in E-Tryton 150, a registry study of the company's Tryton Side Branch stent system.

According to the company, E-Tryton 150 is one of four registries in Europe evaluating the Tryton Side Branch stent system in real-world clinical settings. The registry will enroll 150 patients in several European sites. The primary endpoint of the study is the overall rate of major adverse cardiac events at 6 months after the procedure. Major adverse cardiac events is defined as cardiac death, myocardial infarction, and target lesion revascularization (main and/or side branch). The study will also assess the technical success of the Tryton stent, procedural success, and the rate of target lesion revascularization at 6 months after the procedure.

The company stated that the Tryton 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 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. The company noted that in a first-in-man study of 30 patients, the Tryton Side Branch stent system demonstrated excellent 6-month clinical results with no restenosis occurring in the side branch artery. The stent system received CE Mark approval in Europe in February 2008. It is not yet approved in the United States.