Tryton Medical enrolls first patient in registry study

Oct 12 2010

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced that the first patient has been enrolled in E-Tryton Italy, a registry study of the company's Tryton Side Branch Stent™ System. E-Tryton Italy is one of four registries in Europe evaluating the Tryton Side Branch Stent System in real-world clinical settings.

“I am pleased to enroll the first patient in E-Tryton Italy”

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 standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.

"I am pleased to enroll the first patient in E-Tryton Italy," said Marco Valgimigli, M.D., of the University of Ferrara, Italy, who serves as principal investigator of the study. "Data from the Tryton Side Branch Stent System has been highly promising, and we hope to continue to confirm these excellent results in patients with bifurcation disease in real-world hospital settings in Italy."

Results from 253 patients in the E-Tryton 150 and Benelux registries presented last month during the Transcatheter Cardiovascular Therapeutics (TCT) 2010 conference in Washington, D.C. demonstrated low rates of target lesion revascularization (TLR) and side branch failure (3.6 and 1.2 percent, respectively), with no incidences of stent thromboses.

In addition, 9-month angiographic and IVUS follow-up results from the IUVANT study demonstrated a 3.2 percent rate of TLR, and no stent thromboses.

The E-Tryton Italy registry will enroll at least 300 patients at several sites throughout Italy. The primary endpoint of the study 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 study 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. In addition, the study will include an angiographic and optical coherence technology (OCT) follow-up subgroup.

"We are excited about the benefits that our technology brings to patients with challenging bifurcation lesions. With more than 2,000 patients treated to date, we have received highly positive feedback from physicians on the system's deliverability and ease of use. We look forward to additional real-life practice results from the Tryton Side Branch System," said J. Greg Davis, president and CEO of Tryton Medical.

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 not approved in the United States.