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

Application is supported by results from the pivotal Tryton Confirmatory Study in the treatment of significant coronary bifurcation lesions

URHAM, N.C. 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).

Source: Tryton Medical