December 9, 2009—Tryton Medical, Inc. (Durham, NC) announced the enrollment of the first two patients in TRYTON-LM, a prospective, single-arm study evaluating the feasibility of the Tryton stent in conjunction with the Xience Prime everolimus-eluting coronary stent system (Abbott Vascular, Santa Clara, CA) to treat stable patients with complex de novo bifurcation lesions involving the left main coronary artery. The study will enroll 30 patients who will undergo routine follow-up angiography at 6 to 8 months. Initial results from the first patients included in the registry will be presented at the EuroPCR conference convening in Paris on May 25–28, 2010. Principal Investigator Pieter R. Stella, MD, PhD, enrolled the first patients.

"Left main disease presents unique challenges," commented Dr. Stella. "Today, most left main blockages are left unstented or are addressed with bypass surgery. Tryton's innovative system may offer the ability to definitively treat these lesions, setting the stage for stenting to become the new standard of care for the treatment of left main coronary artery disease, rather than bypass surgery."

According to the company, the Tryton side branch stent system is designed to treat atherosclerotic lesions in the side branch at the site of a bifurcation, a common location for plaque and particularly challenging to treat. The device features a highly deliverable cobalt chromium stent, which 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 stated that the Tryton side branch stent system demonstrated excellent 6-month clinical results in a first-in-man study of the system in 30 patients, with no restenosis occurring in the side branch artery. The stent system has received CE Mark approval in Europe and is not approved in the United States, Tryton advised.