Tryton Medical Receives CE Mark for Larger-Diameter Side Branch Stents

May 18, 2011—Tryton Medical, Inc. (Durham, NC) announced CE Mark approval for larger-diameter sizes of the Tryton side branch stent system for the treatment of coronary artery disease. Launch of the larger-diameter stents, 3 to 3.5 mm and 3.5 to 4 mm, has begun in Europe. The new sizes are designed for larger coronary vessels.

According to Tryton, the device is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. It features a cobalt chromium stent that 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. Clinical results from more than 500 patients with bifurcation lesions have consistently demonstrated target lesion revascularization rates of < 4%.

The stent system has received CE Mark approval in Europe and is commercially available in 21 countries in Europe and the Middle East. In the United States, its use is limited for investigational use only, the company advised.