Positive results presented at Transcatheter Cardiovascular Therapeutics symposium support planned PMA submission.
DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to treat
coronary bifurcation lesions, today announced results from the pivotal
Tryton Confirmatory Study confirming the acceptable acute safety profile
of the Tryton Side Branch Stent for the treatment of coronary
bifurcation lesions in vessels appropriate for a ≥2.5mm stent. Results
are being presented today as part of the Featured Clinical Research
session at Transcatheter Cardiovascular Therapeutics (TCT), the annual
scientific symposium of the Cardiovascular Research Foundation (CRF)
being held in San Francisco, Calif.
The Tryton Confirmatory Study (single-arm clinical trial, n=133) was
designed to validate the acute safety profile of the Tryton Side Branch
Stent shown in a post hoc analysis of the Tryton Randomized
Clinical Trial (RCT, n=704). The post hoc analysis of the Tryton
RCT showed the Tryton Side Branch Stent reduced target vessel failure
and improved side branch percent diameter stenosis when compared with
provisional stenting in the intended treatment population (appropriate
for a ≥2.5mm stent). The Tryton Confirmatory Study showed a
periprocedural myocardial infarction (PPMI) rate (primary endpoint)
meeting the pre-established performance goal, set based on the PPMI rate
of the provisional control arm observed in the Tryton RCT.
Results from the post hoc analysis of the Tryton RCT and the data
from the Tryton Confirmatory Study will be used to support Tryton’s
Premarket Approval (PMA) application for Tryton Side Branch Stent to the
U.S. Food and Drug Administration in the coming weeks.
“These findings provide strong clinical evidence demonstrating that the
Tryton Side Branch Stent provides predictability and durability when
treating coronary bifurcation lesions with significant side branches,
while preserving main vessel results,” said principal investigator Dr.
Martin B. Leon, director of the Center for Interventional Vascular
Therapy at Columbia University Medical Center, New York-Presbyterian
Hospital. “With an established safety profile, Tryton has the potential
to disrupt standard strategies for treating complex bifurcation lesions.”
“These trial results represent a historic milestone in our effort to
advance the Tryton Side Branch Stent to the final stages of regulatory
review in the U.S.,” said Shawn P. McCarthy, president and CEO of Tryton
Medical. “The approval of the first bifurcation stent in the U.S. will
provide clinicians and their patients with a well characterized solution
for one of the greatest unmet clinical needs in interventional
cardiology. We look forward to submitting our PMA in Q4 2015 and,
pending approval, launching Tryton Side Branch Stent in the U.S. in
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 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.
Tryton Medical, Inc.
Judy Gonzalez, 919-226-1490