DURHAM, N.C.--()--Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced activities highlighting the latest experience with the TRYTON Side Branch Stent at the annual Transcatheter Cardiovascular Therapeutics (TCT) 2012 conference taking place Oct. 22 to 26 at the Miami Beach Convention Center in Miami, Fla.
“The use of a dedicated coronary bifurcation stent in patients presenting with myocardial infarction”
- On Tuesday October 23 at 7:00 a.m. ET, Martin B. Leon, M.D., of the Center for Interventional Vascular Therapy at Columbia University Medical Center and Patrick W. Serruys, M.D., Ph.D., of Erasmus University, Rotterdam, Netherlands, will co-chair an overview and update on the Tryton Pivotal IDE Study as part of a TCT satellite symposium titled “Tryton Growing Clinical Data Displacing Provisional Stenting?” in Room C225-C226. The satellite symposium will also include the latest data from a pooled analysis of 905 patients as well as several case presentations.
- Also on Tuesday October 23 from 8:00 a.m. to 10:00 a.m. ET in Hall D, a poster featuring the Tryton Stent titled “The use of a dedicated coronary bifurcation stent in patients presenting with myocardial infarction” will be presented by Maik Grundeken, M.D., of the Department of Cardiology at the University of Amsterdam.
- On Monday October 22 at 11:52 a.m. ET, Dr. Leon, principal investigator of the Tryton IDE Study, will provide an update on the Tryton program during the “Left Main and Bifurcation Stenting: An Advanced Operator's Workshop” session taking place in Junior Ballroom D.
- In addition, on Wednesday October 24 from 10:00 a.m. to 11:00 a.m. ET in Hall D, Indulis Kumsars, M.D. of P. Stradins University Hospital, Latvian Centre of Cardiology, will present a challenging patient case called “Treatment of left main with dedicated bifurcation stent in AMI patient”.
The company will be participating in TCT as an exhibitor in booth #833.
The Tryton stent has now been used to treat more than 6,000 patients and is commercially available throughout Europe, Russia and the Middle East. The company is nearing completion of enrollment in the first and only randomized controlled U.S. IDE pivotal clinical trial evaluating a dedicated bifurcation stent. The 704-patient study 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 trial has completed its IVUS and angiographic sub study cohorts. 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.
Clinical data presented on more than 1,000 patients treated with the Tryton stent has demonstrated consistent target lesion revascularization rates of less than four percent and low thrombosis rates at six-month follow up and beyond.
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.