Tryton Announces CE Mark for Larger-Diameter Sizes of Side Branch Stent

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to
definitively treat bifurcation lesions, today announced receipt of CE
Mark for larger-diameter sizes of the Tryton Side Branch Stent System™
for the treatment of coronary artery disease. Launch of the larger
diameter size stents, 3.0 to 3.5mm and 3.5 to 4.0mm, has begun in
Europe. The new sizes are designed for larger coronary vessels.

“Current treatments for bifurcations have significant limitations,
including higher rates of thrombosis – potentially fatal blood clots –
and restenosis,” said Prof. Robert Van Geuns, associate professor,
Erasmus Medical Center, Rotterdam, Netherlands. “Tryton’s Side Branch
Stent System is an innovative solution to this persistent problem with
impressive acute and long-term clinical outcomes. I am pleased that the
launch of larger sizes of the Tryton Stent System will enable me to
treat additional patients with bifurcations disease.”

“With nearly 3,000 patients now treated and our randomized, multi-center
pivotal trial enrolling patients in the United States, we continue to
see positive momentum for the Tryton Side Branch Stent System,” said
Rick Anderson, board member of Tryton and managing director of PTV
Sciences. “We are pleased that we have been able to respond to
physicians’ requests for larger-diameter sizes of the device, enabling
them to treat a larger portion of their patients with 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. Bifurcation lesions account for
as many as one-third of all coronary lesions.¹

About the Tryton Side Branch Stent

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 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.

Clinical results from more than 500 patients with bifurcation lesions
have consistently demonstrated target lesion revascularization (TLR)
rates of less than four percent.

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 approved in the United States for investigational use only.

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.

¹ Scot Garg, et al. EuroIntervention 2011:6: 928-935.
Available online at http://www.pcronline.com/eurointervention/34th_issue/162/