Positive Real-World Data From Tryton Stent System Presented at Joint Interventional Meeting in Rome

DURHAM, N.C.--Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced that more than 4000 patients have been treated with the company’s Tryton™ Side Branch Stent in Europe, Russia and the Middle East.

New data continues to demonstrate positive results for the Tryton side branch stent. Results from 250 patients in the SAFE-TRY registry were presented last week by Giuseppe Tarantini, M.D., of the department of Cardiac, Thoracic and Vascular Sciences at the University of Padova, Italy, during the annual Joint Interventional Meeting (JIM) in Rome.

SAFE-TRY is a prospective, multicenter registry to test safety and feasibility of the Tryton stent to treat de novo bifurcation lesions. Findings showed a rate of target lesion revascularization (TLR) of 4.8 percent at nine months follow up, and no incidents of late stent thrombosis.

“This real-world data continues to reinforce the excellent safety and effectiveness of the Tryton stent system,” said Dr. Tarantini. “The results are especially impressive because of the inclusion of complex bifurcations and left main lesions, which are particularly difficult to treat. These results underscore why the Tryton stent represents the standard of care in my lab.”

“In study after study, Tryton has demonstrated consistently favorable results, with TLR rates around 4 percent in more than 900 patients at greater than six months follow up,” said Shawn P. McCarthy, president and CEO of Tryton Medical. "Our commitment to generating meaningful clinical outcomes is clear, as we remain on schedule to complete enrollment in the landmark randomized Tryton IDE study this year. We are carrying significant momentum into 2012, with more than 4,000 patients treated with the Tryton side branch stent demonstrating substantive adoption and routine use in clinical practice."

The Tryton stent is being studied in the first and only randomized U.S. IDE clinical trial evaluating dedicated bifurcation stents in 704 patients. The results of the trial will be submitted to the U.S. Food and Drug Administration (FDA) for approval to market the device in the United States.

Source: Tryton Medical, Inc.