Tryton Medical Announces Publication of Post Hoc Analysis of Randomized Clinical Trial in Treatment of Bifurcation Lesions using 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 results of a post hoc
analysis of the pivotal Tryton Randomized Clinical Trial (RCT) have been
published in the peer-reviewed journal Catheterization and
Cardiovascular Interventions (CCI), the official publication of the
Society for Cardiovascular Angiography and Interventions (SCAI). The
analysis, “Outcomes
of a dedicated stent in coronary bifurcations with large side branches:
A subanalysis of the randomized TRYTON bifurcation study,”
examines the use of the Tryton Side Branch Stent compared with
provisional stenting in the intended treatment population of patients
with a coronary bifurcation lesion in vessels 2.25mm in diameter or
greater determined by quantitative coronary angiography (QCA).

The study authors, led by Martin B. Leon, MD, director of the Center for
Interventional Vascular Therapy at Columbia University Medical Center,
New York-Presbyterian Hospital, conclude that treatment with the Tryton
Side Branch Stent showed reductions in target vessel failure and
improved side branch percent diameter stenosis in the population of
patients with lesions involving side branches that were 2.25mm in
diameter or greater. Both the Tryton Side Branch Stent and provisional
treatment strategies were shown to have similarly low rates of stent
thrombosis and no cardiac deaths were reported at nine months.

“Coronary bifurcation lesions present a number of challenges for
interventional cardiologists because each patient can present with
varying vessel sizes and there is a wide range of angulations between
the main vessel and side branch,” said Dr. Leon. “For the treatment of
bifurcation lesions involving significant side branches, this analysis
of the pivotal Tryton RCT provides strong support for the safety and
efficacy of the Tryton Side Branch Stent compared with a provisional
stenting strategy.”

In the post hoc analysis of 289 patients with a coronary bifurcation
lesion involving a side branch greater than or equal to 2.25mm in
diameter, target vessel failure, the primary endpoint, was numerically
lower among the Tryton group compared to the provisional group. The
Tryton Side Branch Stent demonstrated a statistically significant lower
side branch percent diameter stenosis at nine month follow up compared
with the provisional group (30.4% vs. 40.6%, P = 0.004). In addition,
the Tryton Side Branch Stent reduced the need for additional side branch
“bail-out” stenting compared with the provisional approach (0.7% vs.
5.6%, P = 0.02). There was no significant difference in the rate of
binary restenosis.

“We welcome the results of this post hoc analysis in patients with large
side branches as an important step towards bringing a dedicated stent to
cardiologists in the United States, and addressing challenges in
treating significant coronary bifurcation lesions,” said Shawn P.
McCarthy, president and CEO of Tryton Medical. “We recently completed
enrollment in the Tryton Confirmatory Study, a single-arm study of our
dedicated stent designed to confirm results from the pivotal Tryton RCT
study in our intended population of patients with coronary bifurcation
lesions involving side branches that are 2.25mm in diameter or greater.
We plan to present findings from this study at the Transcatheter
Cardiovascular Therapeutics (TCT) 2015 meeting in the coming weeks.”

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 US, 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 Dartmouth Medical School/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.