Tryton Medical has filed the final module of its pre-market approval (PMA) to US Food and Drug Administration (FDA) for its Side Branch Stent system.
The system was developed using Tri-ZONE technology to treat bifurcation lesions. Following approval from the FDA, the Side Branch Stent system is expected to become the first bifurcation stent in the US.
By using a standard single wire balloon expandable stent delivery system, the cobalt chromium stent will be deployed in the side branch artery, while a conventional drug eluting stent will be placed in the main vessel.
The PMA is supported by data from the single-arm Tryton confirmatory study, which showed 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 from the Tryton randomised clinical trial showed the stent reduced target vessel failure and improved side branch percent diameter stenosis, when compared to provisional stenting in the intended treatment population.
Tryton Medical president Shawn McCarthy said: "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.
"With today’s PMA filing we are one step closer to providing an important new option for interventional cardiologists in the US working to improve the quality of care for patients suffering from coronary artery disease."
The Side Branch Stent has been used to treat more than 11,000 patients worldwide and is marketed in multiple countries within Europe, Middle East and Africa.
The company noted the stent is investigational in the US and is not available in Japan.