Research Triangle Park, N. C. and Brussels – April 22, 2010 – Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced the launch of the TRYTON Side Branch Stent™ System in Austria, Belgium, Denmark, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, and the United Kingdom. The stent is used to treat bifurcation lesions, the largest unmet need confronting interventional cardiology.
“The Tryton Side Branch Stent System offers a unique solution to a persistent problem – how to treat patients with lesions at or near areas of bifurcation in the coronary circulation, a site vulnerable to high rates of restenosis,” said Michael Norell, M.D., Department of Cardiology, The Heart and Lung Centre, Wolverhampton, UK. “I have been using the Tryton Side Branch System for more than a year now and have found it to be the ideal solution for these difficult cases. I am excited that the Tryton Stent will now be more widely available to physicians and patients in Europe.”
More than 1,000 patients in Europe have been treated with the Tryton Side Branch Stent System, with more than 500 part of a registry or an investigator-lead clinical trial.
“We are pleased with the positive response from physicians to the Tryton Side Branch Stent System in Europe to date, with more than a thousand patients benefiting from treatment with the Tryton Side Branch System,” said J. Greg Davis, president and CEO of Tryton Medical. “We are thrilled to widen European availability with this launch, and anticipate commercializing in additional countries in the coming weeks.”
Areas of bifurcation in the vascular system are a common location for plaque and are particularly challenging to treat with currently available stent systems. 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. Approximately twenty-two percent of patients treated for coronary artery disease have diseased bifurcated lesions.
The left main coronary artery is a common location for bifurcation disease. Today, most left main blockages are left unstented or are addressed with bypass surgery. Tryton’s stent has also demonstrated effectiveness in the left main coronary artery.
About the Tryton Side Branch Stent System
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 highly deliverable 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 Tryton Side Branch Stent System demonstrated excellent six-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 commercially available in Austria, Belgium, Denmark, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, and the United Kingdom. It is not approved in the United States.
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`s Side Branch Stent System, approved for sale in Europe, is designed to offer a dedicated strategy for treating these challenging cases. The privately held company is backed by Spray Ventures, PTV Sciences, and RiverVest Ventures. For more information please visit www.trytonmedical.com.
