DURHAM, N.C.--(BUSINESS WIRE)--Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced results of a patient-level pooled analysis of six-month clinical outcomes of the TRYTON Side Branch Stent. Findings were presented last week in Paris at EuroPCR, the official congress of the European Association of Percutaneous Cardiovascular Interventions.
Data from 905 patients treated with the Tryton stent in eight European post-marketing registries demonstrated low target lesion revascularization rates of 2.9 percent at six months and 4.0 percent at one year, and a low 0.5 percent thrombosis rate at one year.
“The consistently excellent results for the Tryton stent system in hundreds of patients should provide physicians with a great deal of confidence when choosing a strategy for treating bifurcation lesions,” said EuroPCR course director William Wijns, M.D., of the Cardiovascular Center in Aalst, Belgium. “In study after study, the Tryton stent has shown positive and predictable results for these complex cases, and this solution allows Tryton to challenge the dogma of provisional stenting for the treatment of bifurcation lesions whenever larger side branches are involved.”
Results of the pooled analysis were featured in a “Tools and Techniques” session chaired by Dr. Wijns and Martin B. Leon, M.D., of Columbia University, New York. The session featured two successful live case transmissions using the Tryton stent, including a left main bifurcation, by Eulogio Garcia, M.D., of the Hospital Clinico San Carlos in Madrid, Spain.
“For me, the key benefit of the Tryton stent is predictability,” said Dr. Garcia. “Using the Tryton, you can predict that at the end of the procedure you will have good results in both the side branch and the main vessel. In addition, there is no question that the Tryton stent has simplified the treatment of distal bifurcation of the left main.”
“Tryton Medical is emerging as the clear leader in bifurcation treatment, evidenced by an impressive presence at EuroPCR, where three live Tryton case transmissions were performed, 14 Tryton case reports discussed, and three Tryton clinical abstracts presented. We also announced our 5,000th implant, demonstrating deep adoption and routine use in clinical practice,” said Shawn P. McCarthy, president and CEO of Tryton Medical. "The Tryton Side Branch Stent represents a new growth driver in interventional cardiology. In addition to offering an innovative solution for bifurcations, our device holds potential for left main disease, which could generate a combined market opportunity of approximately 700,000 procedures annually worldwide.”
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. In patients undergoing PCI-stenting, approximately one-third have 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 Pivotal Study
The landmark Tryton pivotal 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 pivotal clinical trial evaluating a dedicated bifurcation stent, will enroll 704 patients at 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. The IVUS and angiographic sub study cohorts have closed enrollment and the trial remains on schedule to fully enroll later this year.
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.