Tryton Side Branch Stent System offers new treatment strategy for atherosclerotic lesions

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced interim six-month results from the company's E-Tryton registry evaluating the TRYTON Side Branch Stent™ System at 15 European sites.

“In addition, the device is easy to use, with a 99 percent stent delivery success rate.”

Results were presented by David P. Foley, M.D., of Beaumont Hospital & Royal College of Surgeons in Ireland, during the annual European Bifurcation Club meeting this week in Budapest, Hungary.

Findings from 296 patients demonstrated low rates of target lesion revascularization (TLR) and side branch failure (3.1 and 1 percent, respectively).

"This real-world, all-comers study continues to demonstrate impressive data - including drug eluting stent-like results in both the main vessel and side branch, making Tryton's stent a highly compelling strategy for treating bifurcation lesions," said Prof. Foley. "In addition, the device is easy to use, with a 99 percent stent delivery success rate."

"We are pleased that the growing body of data from patients treated with the Tryton stent system continues to confirm the excellent clinical results we have seen previously," said J. Greg Davis, president and CEO of Tryton Medical. "Thousands of European patients with difficult-to-treat cases have now been helped by physicians utilizing our device. We look forward to beginning a randomized pivotal trial to gather data for submission to the U.S. Food and Drug Administration in the coming months so that we can also bring this therapy to U.S. physicians and patients."

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.