DURHAM, N.C.--(BUSINESS WIRE)--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.
About Coronary Bifurcation Disease
Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. 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.1 In patients undergoing PCI-stenting, approximately one-third has a bifurcation lesion. Left main disease, an accumulation of plaque that narrows the base of the coronary tree, is a persistent challenge in interventional cardiology, as more than 75 percent of left main lesions are bifurcation lesions.
About the Tryton Side Branch Stent
The Tryton Side Branch Stent System is built for bifurcation using proprietary Tri-zone™ technology to offer a dedicated strategy for treating bifurcation lesions. Tryton’s 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 and is commercially available throughout Europe, Russia and the Middle East. It is approved in the United States for investigational use only.
About the Randomized Tryton IDE Study
The landmark Tryton IDE study is a multi-national randomized trial that compares a Tryton stent in the side branch vs. the use of balloon angioplasty in the side branch, with both arms of the trial utilizing a standard drug eluting stent in the main vessel. The study, which is the first and only randomized IDE clinical trial of a bifurcation stent, will enroll over 700 patients from up to 75 centers in North America, Europe and Israel. Martin Leon, M.D. (Columbia University, New York) serves as principal investigator for the study and Patrick Serruys (Thoraxcenter, Rotterdam) is leading IVUS and three-dimensional angiographic analysis.
About Tryton Medical, Inc.
Tryton Medical, Inc., located in Durham, N.C., is a leading developer of novel stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of medicine at Dartmouth Medical School/Dartmouth- Hitchcock Medical Center) and Dan Cole to develop stents for the definitive treatment of bifurcation lesions. Privately held, Tryton is backed by Arnerich Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest Ventures. For more information please visit www.trytonmedical.com.