Tryton Medical has received a CE mark for its larger-diameter size—3.0 to 3.5 mm and 3.5 to 4.0 mm—Tryton Side Branch Stent System used during treatment of coronary artery disease.
The cobalt chromium stent system is designed to treat atherosclerotic lesions located within the side branch at the site of a bifurcation and the device is deployed in the side branch artery using a single-wire balloon-expandable stent system, according to Durham, N.C.-based Tryton. A drug-eluting stent is then placed in the main vessel.
The CE mark was based off of previous research that showed a target lesion revascularization rate of less than four percent in more than 500 patients with bifurcation lesions treated with the device. Currently, Tryton is conducting a randomized controlled trial enrolling 3,000 patients.
The company said that the stent system is now approved for use in 21 countries throughout Europe and the Middle East. However, the device is not approved in the U.S. and is for investigational use only.