Tryton Medical Files Pre-Market Approval Application with US FDA for Tryton Side Branch Stent

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to treat
coronary bifurcation lesions, today announced that it has filed the
final module of its Pre-Market Approval (PMA) application with the U.S.
Food and Drug Administration (FDA) for the Tryton Side Branch Stent. If
approved, the Tryton Side Branch Stent would become the first
bifurcation stent available in the U.S.

“Tryton Medical’s differentiated technology addresses the unique
challenges of bifurcated lesions, which affect nearly a third of all
patients treated with angioplasty each year,” said Shawn P. McCarthy,
president and CEO of Tryton Medical. “With today’s PMA filing we are one
step closer to providing an important new option for interventional
cardiologists in the U.S. working to improve the quality of care for
patients suffering from coronary artery disease.”

The application is supported by results from the pivotal Tryton
Confirmatory Study (single-arm clinical trial, n=133) presented
at the 2015 Transcatheter Cardiovascular Therapeutics symposium,
which established an acceptable acute safety profile for the treatment
of coronary bifurcation lesions in vessels appropriate for a ≥2.5mm
stent. In addition, a post hoc analysis of the Tryton Randomized
Clinical Trial (n=704) published
in the journal Catheterization and Cardiovascular Interventions
showed the Tryton Side Branch Stent reduced target vessel failure and
improved side branch percent diameter stenosis when compared to
provisional stenting in the intended treatment population (appropriate
for a ≥2.5mm stent).

About Tryton Side Branch Stent

Tryton Side Branch Stent System is built 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. Tryton Side Branch Stent has now been used to treat more than
11,000 patients worldwide. The Tryton Side Branch Stent is commercially
available in multiple countries within Europe, Middle East & Africa, is
investigational in the U.S., and is not available in Japan.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Durham, N.C., is the 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 the Geisel School of Medicine/Dartmouth-Hitchcock Medical
Center, to develop stents for the definitive treatment of bifurcation
lesions. For more information please visit trytonmedical.com
and follow the company on Twitter at @TrytonMedical1.