DURHAM, N.C.--()--Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced the latest data from a pooled analysis of 905 patients treated with the Tryton Side Branch Stent.™ Results were presented last week in Miami, Fla., by Joanna J. Wykrzykowska, M.D., Ph.D., of the University of Amsterdam as part of a standing-room-only Transcatheter Cardiovascular Therapeutics (TCT) 2012 satellite symposium co-chaired by Professors Martin B. Leon, M.D., of Columbia University Medical Center in New York and Patrick W. Serruys, M.D., Ph.D., of Erasmus University, Rotterdam, Netherlands.
“I believe that the growing and consistently positive body of clinical data for the Tryton stent does in fact position the device as an attractive alternative to traditional provisional stenting techniques.”
In addition, the company announced live satellite transmissions of two successful clinical cases using the Tryton stent to audiences of over 1,000 interventional cardiologists attending the conference.
Data from the analysis of eight registry studies showed that in the real-world setting, the rate of target lesion revascularization (TLR) for bifurcation lesions treated with the Tryton stent was 4 percent at one year, with a stent thrombosis rate of 0.5 percent.
“This analysis shows that the use of the Tryton stent is associated with procedural and mid-term clinical results that compare favorably with previous smaller studies of the device and with large studies of other techniques. The low stent thrombosis rate is particularly encouraging, given the association of bifurcation lesions with a historically higher risk for stent thrombosis,” said Dr. Wykrzykowska. “I believe that the growing and consistently positive body of clinical data for the Tryton stent does in fact position the device as an attractive alternative to traditional provisional stenting techniques.”
These results and other findings from various registries were confirmed in SAFE-Try, the largest prospective multicenter trial to date of the Tryton stent, which evaluated safety and efficacy in 251 patients. Data, which were presented at TCT by Giuseppe Tarantini of the University of Padua in Padua, Italy, showed a TLR of 4.4 percent and zero stent thrombosis at nine months.
During the satellite symposium, Professors Leon and Serruys provided an overview and update on the Tryton Pivotal IDE Study, 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.
“It’s clear that bifurcation disease represents a significant unmet clinical need, evidenced by the overflowing attendance at symposia throughout the week,” said Shawn P. McCarthy, president and CEO of Tryton Medical. “Momentum for Tryton Medical continues to build, with more than 6,000 patients now treated with our stent system around the world and completion of enrollment in our U.S. pivotal IDE study expected in the coming days. We look forward to submitting results of the trial to FDA for approval and to introducing our technology in the United States.”
The Tryton stent is commercially available throughout Europe, Russia and the Middle East. 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.