Durham, N.C. – Dec. 9, 2009 – Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today 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 Abbott’s XIENCE PRIME™ Everolimus Eluting Coronary Stent System 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 a routine follow-up angiogram at six to eight months. Initial results from the first patients included in the registry will be presented at the annual EuroPCR conference taking place May 25 to 28, 2010 in Paris.
The first patients were enrolled by Pieter R. Stella, M.D., Ph.D., director of the Heart Catheterization Laboratories and Clinical Cardiovascular Research at the University Medical Centre in Utrecht, the Netherlands, who serves as principal investigator for the study.
“Left main disease presents unique challenges. 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,” said Dr. Stella.
“The Tryton Side Branch Stent has now been implanted in more than 500 European patients. This rapid adoption, in a limited number of centers, demonstrates significant repeat usage and is especially gratifying,” said J. Greg Davis, president and CEO of Tryton Medical. “We believe the Tryton-LM registry will help us understand how the Tryton Side Branch Stent may provide a solution for these difficult-to-treat bifurcation lesions.”
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. These areas of the vascular system are a common location for plaque and are particularly challenging to treat with currently available stent systems. Approximately twenty-two percent of patients treated for coronary artery disease have diseased bifurcated lesions.
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 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.
