Tryton Announces DRG Reimbursement Code For Side Branch Stent in Germany

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 Tryton’s 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 23^rd
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.¹ 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. 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 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 trytonmedical.com.