Tryton Announces First Patient Enrollment in E-Tryton 150 Registry

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Tue Jun 30, 2009 7:00am EDT

Study Will Assess Tryton Side-Branch Stent in Real-World Settings
RESEARCH TRIANGLE PARK, N.C.--(Business Wire)--
Tryton Medical, Inc., the leading developer of stents designed to definitively
treat bifurcation lesions, today announced enrollment of the first patient in
E-Tryton 150, a registry study of the company`s TRYTON Side Branch Stent System.
E-Tryton 150 is one of four registries in Europe evaluating the Tryton Side
Branch Stent System in real-world clinical settings. 

The Tryton Side Branch Stent is designed to offer a dedicated strategy for
treating atherosclerotic lesions at the site of a bifurcation. Bifurcation
lesions have presented a challenge for cardiologists since the earliest days of
angioplasty. Current approaches to treating these lesions have significant
limitations. 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. 

"I am thrilled to participate in E-Tryton 150," said Dr. Eulogio Garcia. "Early
data for the Tryton Side Branch Stent System is very promising, and we hope to
confirm these excellent results in patients with bifurcation disease in
real-world hospital settings. The Tryton Stent is easy to use and we are happy
to start using it in our daily clinical practice." 

The E-Tryton 150 registry will enroll 150 patients in several European sites.
The primary endpoint of the study is the overall rate of major adverse cardiac
events (MACE) at six months following the procedure. MACE is defined as cardiac
death, myocardial infarction and target lesion revascularization (main and/or
side branch). The study will also assess the technical success of the Tryton
stent, procedural success, and the rate of target lesion revascularization (TLR)
at six (6) months after the procedure. 

"We`re very pleased to begin enrollment in E-Tryton," said J. Greg Davis,
president and CEO of Tryton Medical. "We are excited about the benefits that our
technology promises for patients with cardiovascular disease, and we look
forward to real-life practice results of the study." 

About the Tryton Side-Branch Stent System

The Tryton Side Branch Stent System is designed to offer a dedicated strategy
for treating atherosclerotic lesions in the side branch at the site of a
bifurcation. These areas of the vascular system are a common location for plaque
and are particularly challenging to treat with currently available stent
systems. Approximately twenty percent of patients treated for coronary artery
disease are treated for bifurcated lesions. The Tryton Side Branch Stent System
received CE mark approval in February 2008. 

Tryton`s highly deliverable 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 Tryton Side Branch Stent System demonstrated excellent six-month clinical
results in a first-in-man study of the system in 30 patients, with no restenosis
occurring in the side-branch artery. The stent system has received CE Mark
approval in Europe and is not approved in the United States. 

The Tryton Side Branch Stent System is used in conjunction with a conventional
drug-eluting stent. 

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`s Side
Branch Stent System, approved for sale in Europe, is designed to offer a
dedicated strategy for treating these challenging cases. The privately held
company is backed by Spray Ventures, PTV Sciences, RiverVest Ventures. For more
information please visit www.trytonmedical.com. 



for Tryton Medical, Inc.
Nicole Osmer, 650-454-0504
nicole@nicoleosmer.com


Copyright Business Wire 2009

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