Tryton Medical Announces Publication of Data from Pivotal Trial for Tryton Side Branch Stent in Journal of American College of Cardiology

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents to treat
bifurcation lesions, today announced that results from the company’s
pivotal clinical trial for the Tryton Side Branch Stent were published
in the Journal of the American College of Cardiology. The Tryton
Pivotal IDE Trial, which enrolled 704 patients at 67 centers in North
America and in 11 countries in the EU and Israel, was the largest
coronary bifurcation study ever conducted.

The Tryton Pivotal IDE trial was a randomized study comparing the Tryton
Side Branch Stent to conventional provisional treatment with balloon
angioplasty in the side branch. Both study groups were treated with
standard drug eluting stents in the main vessel. Among the 704 patients
in the study, fully 60 percent of side-branch vessels treated were
smaller than 2.25 mm diameter by QCA. The intended population for the
trial included patients presenting with side branch vessels of 2.25mm
diameter or greater by QCA.

In an article entitled “A Randomized Trial of a Dedicated Bifurcation
Stent Versus Provisional Stenting in the Treatment of Coronary
Bifurcation Lesions,” researchers reported that while the study
did not meet its primary endpoint of non-inferiority in measures of
target vessel failure (TVF) in the overall population of patients
treated, post-hoc analysis of outcomes in the intended study population
of 289 patients with side branch vessels of 2.25 mm diameter or greater
by QCA showed reductions in TVF and side branch percent diameter
stenosis with the Tryton stent. In addition, both the Tryton and
provisional treatment strategies were shown to have similarly low rates
of stent thrombosis and no cardiac deaths reported at nine months.

“The Tryon IDE Study is a landmark clinical trial representing the
coordinated efforts of leading investigators in the U.S. and Europe,”
stated Philippe Genereux, M.D., director of the Core Angiographic
Laboratories at the Cardiovascular Research Foundation and the
lead author of the manuscript. “The most important finding was the
performance of the Tryton Stent in the intended population presenting
with complex bifurcations involving significant side branches. In this
population, Tryton showed a reduction
of TVF within the non-inferiority
margin pre-specified for the entire population and significantly reduced
side branch percent diameter stenosis.”

“As we reported in October 2014, analysis of the findings from the
Pivotal IDE Trial for Tryton Side Branch Stent indicates significant
benefit in the intended treatment population. Based on these important
findings, Tryton has initiated The Tryton Extended Access Registry, a
single arm study of the Tryton Side Branch Stent designed to confirm
results from the Pivotal IDE Trial in the intended treatment population
of patients with lesions involving significant side bifurcation,” said
Shawn P. McCarthy, president and CEO of Tryton Medical. “We remain on
schedule to complete enrollment and file our pre-market approval
application with the FDA this year.”

Coronary artery disease often results in the buildup of plaque at the
site of a bifurcation, where one artery branches from another. Current
treatment options 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. In patients undergoing PCI-stenting,
approximately one-third have a bifurcation lesion. Left main disease, an
accumulation of plaque that narrows the base of the coronary tree, is a
persistent challenge in interventional cardiology, as more than 75
percent of left main lesions are bifurcation lesions

About the Tryton Side Branch Stent System

The Tryton Side Branch Stent System is built for bifurcation 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. The Tryton Side Branch Stent is
commercially available in multiple countries in the EU, Middle East and
Asia, and is investigational in the U.S.

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. For
more information please visit trytonmedical.com
and follow the company on Twitter at @TrytonMedical1.