Tryton Announces First Patient Enrollment in E-Tryton Italy Registry of the Tryton Side Branch Stent System

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to
definitively treat bifurcation lesions, today announced that the first
patient has been enrolled in E-Tryton Italy, a registry study of the
company’s Tryton Side Branch Stent™ System. E-Tryton Italy is one of
four registries in Europe evaluating the Tryton Side Branch Stent System
in real-world clinical settings.

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. Tryton’s highly deliverable cobalt chromium stent
is deployed in the side branch artery using standard single-wire
balloon-expandable stent delivery system. A conventional drugeluting
stent is then placed in the main vessel.

“I am pleased to enroll the first patient in E-Tryton Italy,” said Marco
Valgimigli, M.D., of the University of Ferrara, Italy, who serves as
principal investigator of the study. “Data from the Tryton Side Branch
Stent System has been highly promising, and we hope to continue to
confirm these excellent results in patients with bifurcation disease in
realworld hospital settings in Italy.”

Results from 253 patients in the E-Tryton 150 and Benelux registries
presented last month during the Transcatheter Cardiovascular
Therapeutics (TCT) 2010 conference in Washington, D.C. demonstrated low
rates of target lesion revascularization (TLR) and side branch failure
(3.6 and 1.2 percent, respectively), with no incidences of stent
thromboses.

In addition, 9-month angiographic and IVUS follow-up results from the
IUVANT study demonstrated a 3.2 percent rate of TLR, and no stent
thromboses. The E-Tryton Italy registry will enroll at least 300
patients at several sites throughout Italy. 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. In
addition, the study will include an angiographic and optical coherence
technology (OCT) follow-up subgroup.

“We are excited about the benefits that our technology brings to
patients with challenging bifurcation lesions. With more than 2,000
patients treated to date, we have received highly positive feedback from
physicians on the system’s deliverability and ease of use. We look
forward to additional real-life practice results from the Tryton Side
Branch System,” said J. Greg Davis, president and CEO of Tryton Medical.

The stent system has received CE Mark approval in Europe and is
commercially available in 21 countries throughout Europe and the Middle
East. It is not approved in the United States.

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. The Tryton Side Branch Stent System, approved for
sale in Europe, is designed to offer a dedicated strategy for treating
these challenging cases. Privately held, Tryton is backed by Arnerich
Massena & Associates, Spray Ventures, PTV Sciences, and RiverVest
Ventures. For more information please visit trytonmedical.com.