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Tryton announces enrollment completion of two European registries

April 08, 2010 By: NCTechNews Category: Medical Devices

(Research Triangle Park, N.C.) Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced completion of enrollment in E-Tryton 150 and E-Tryton Benelux, two European registry studies of the company’s TRYTON Side Branch Stent™ System for the treatment of atherosclerotic lesions in the side branch at the site of a bifurcation.

Tryton Medical is conducting various registries in Europe evaluating the Tryton Side Branch Stent System in real-world clinical settings. In addition to E-Tryton 150 and E-Tryton Benelux, E-Tryton Spain (TRES) continues to enroll patients.

More than 1,000 patients in Europe have been treated with the Tryton Side Branch Stent System.

“Early data for the Tryton Side Branch Stent System is very promising. The E-Tryton studies will help us understand the use of the TRYTON Side Branch Stent System in real-world practice,” said 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 participated in E-Tryton Benelux.

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 E-Tryton 150 study enrolled 151 patients, and E-Tryton Benelux enrolled 155. The primary endpoint of the studies is the overall rate of major adverse cardiac events (MACE) at six months following the procedure. MACE is defined as cardiac death, myocardial infarction and target lesion revascularization (main and/or side branch). The studies will also assess the technical success of the Tryton stent, procedural success, and the rate of target lesion revascularization (TLR) at six (6) months after the procedure.

“Completion of enrollment in E-Tryton 150 and E-Tryton Benelux are important milestones for Tryton,” said J. Greg Davis, president and CEO of Tryton Medical. “We look forward to completing enrollment in E-Tryton Spain (TRES) and sharing the real-life practice results of these studies.”  

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 not approved in the United States.

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.

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