DURHAM, N.C.--(BUSINESS WIRE)--Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced receipt of CE Mark for larger-diameter sizes of the Tryton Side Branch Stent System™ for the treatment of coronary artery disease. Launch of the larger diameter size stents, 3.0 to 3.5mm and 3.5 to 4.0mm, has begun in Europe. The new sizes are designed for larger coronary vessels.
“Current treatments for bifurcations have significant limitations, including higher rates of thrombosis – potentially fatal blood clots – and restenosis,” said Prof. Robert Van Geuns, associate professor, Erasmus Medical Center, Rotterdam, Netherlands. “Tryton’s Side Branch Stent System is an innovative solution to this persistent problem with impressive acute and long-term clinical outcomes. I am pleased that the launch of larger sizes of the Tryton Stent System will enable me to treat additional patients with bifurcations disease.”
“With nearly 3,000 patients now treated and our randomized, multi-center pivotal trial enrolling patients in the United States, we continue to see positive momentum for the Tryton Side Branch Stent System,” said Rick Anderson, board member of Tryton and managing director of PTV Sciences. “We are pleased that we have been able to respond to physicians’ requests for larger-diameter sizes of the device, enabling them to treat a larger portion of their patients with bifurcation disease.”
Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. Bifurcation lesions account for as many as one-third of all coronary lesions.1
About the Tryton Side Branch Stent
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. Tryton’s 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.
Clinical results from more than 500 patients with bifurcation lesions have consistently demonstrated target lesion revascularization (TLR) rates of less than four percent.
The stent system has received CE Mark approval in Europe and is commercially available in 21 countries throughout Europe and the Middle East. It is approved in the United States for investigational use only.
About Tryton Medical, Inc.
Tryton Medical, Inc., located in Durham, N.C., is a leading developer of novel stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of medicine at Dartmouth Medical School/Dartmouth- Hitchcock Medical Center) and Dan Cole to develop stents for the definitive treatment of bifurcation lesions. The Tryton Side Branch Stent System, approved for sale in Europe, is designed to offer a dedicated strategy for treating these challenging cases. Privately held, Tryton is backed by Arnerich Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest Ventures. For more information please visit www.trytonmedical.com.
1 Scot Garg, et al. EuroIntervention 2011:6: 928-935. Available online at http://www.pcronline.com/eurointervention/34th_issue/162/