DURHAM, N.C.--(BUSINESS WIRE)--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.
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.