A press release from Tryton Medical has announced that the final module of the Tryton Side Branch Stent’s pre-market approval (PVA) has been filed with the US Food and Drug Administration (FDA). This product could become the first bifurcation stent available in the USA if approved.
Shawn P. McCarthy, president and CEO of Tryton Medical says, “With today’s PMA filing we are one step closer to providing an important new option for interventional cardiologists in the USA.”
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 (TCT) 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).