Tryton reports positive interim results from Side Branch Stent System study

Sep 30 2010

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, announced interim six-month results from a symposium during the Transcatheter Cardiovascular Therapeutics (TCT) 2010 conference in Washington, D.C.

“We're pleased that these results confirm positive outcomes seen in earlier studies, including excellent six-month clinical and angiographic results in our first-in-man study and excellent six-month clinical results from four different registries. All of these studies show a low rate of TLR”

Results from 253 patients in the E-Tryton registry presented by David P. Foley, M.D., of Beaumont Hospital & Royal College of Surgeons in Ireland, 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, Antonio L. Bartorelli, M.D., of the University of Milan presented 9-month angiographic and IVUS follow-up results from the IUVANT study demonstrating a 3.2 percent rate of TLR, and no stent thromboses.

"These preliminary data suggest that the Tryton stent provides a reliable and reproducible strategy to stent the side branch and its origin, showing complete scaffolding and coverage of the side branch ostium and very modest in-stent neo-intimal growth at follow-up," concluded Prof. Bartorelli.

"We're pleased that these results confirm positive outcomes seen in earlier studies, including excellent six-month clinical and angiographic results in our first-in-man study and excellent six-month clinical results from four different registries. All of these studies show a low rate of TLR," said J. Greg Davis, president and CEO of Tryton Medical.

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 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.