DURHAM, N.C.–(BUSINESS
WIRE)–Tryton Medical, Inc., the leading developer of stents designed to
definitively treat bifurcation lesions, announced that the German Institute for
Medical Documentation and Information (DIMDI, Cologne) has revised the
procedure code for the treatment of coronary bifurcations lesions,
distinguishing dedicated side branch stent systems from conventional technique
and providing for additional reimbursement for use of the Tryton side branch
stent.
“This favorable reimbursement decision in Germany is
evidence of continued market acceptance of the Tryton stent, which has now been
used to treat more than 3,500 patients worldwide,” said Shawn P. McCarthy,
president and CEO of Tryton Medical. “The expanded reimbursement validates our
commitment to providing data supporting Trytons use in this problematic lesion
subset.”
“Treating bifurcation lesions is a common, challenging
problem for interventional cardiologists,” said Professor Jai-Wun Park of
Asklepios Klinik Hamburg, Germany, who received the “Best Challenging Case
Award” for a challenging patient case treated with the Tryton stent at the 23rd
Annual Transcatheter Therapeutics (TCT) conference last month in San Francisco. “Tryton
offers a solution with excellent efficacy and safety in a large and growing
body of clinical data. In addition, and just as importantly, Tryton provides me
with the confidence to easily treat these difficult lesions with the
reliability I associate with more straightforward cases. It has become a
mainstay in my clinical practice.”
Clinical data presented on more than 800 patients treated
with the Tryton stent has demonstrated consistent target lesion
revascularization rates of less than four percent at greater than six months
follow up.
In addition, the Tryton stent is also being studied in the
first and only randomized IDE clinical trial evaluating dedicated bifurcated
stents. More than one-third of the 704 patients have been enrolled to date in
the Tryton IDE study. 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. 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. Trytons 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
More than one third of the patients have been enrolled to date in the landmark
Tryton IDE study, 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,
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.
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.
Posted by Sean Fenske, Editor-in-Chief, MDT
