Application is supported by results from the pivotal Tryton Confirmatory Study in the treatment of significant coronary bifurcation lesions.
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 www.trytonmedical.com and follow the company on Twitter at @TrytonMedical1.