Tryton Medical is seeking approval from the US Food and Drug Administration (FDA) for its Side Branch Stent system, which was developed using Tri-ZONE technology to treat bifurcation lesions.
The company has filed the final module of its pre-market approval (PMA) with the FDA for the stent, which is expected to become the first bifurcation stent in the US, if approved.
Using a standard single wire balloon-expandable stent delivery system, the cobalt chromium stent will be deployed in the side branch artery. A conventional drug eluting stent will then be placed in the main vessel.
The PMA was submitted based on the results of the single-arm Tryton Confirmatory Study, which demonstrated an acceptable acute safety profile for the treatment of coronary bifurcation lesions in vessels.
The post hoc analysis of the Tryton Randomized clinical trial also demonstrated that Tryton Side Branch Stent reduced target vessel failure and improved side branch percent diameter stenosis compared against provisional stenting in the intended treatment population.
Tryton Medical president and CEO 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."
Tryton Side Branch Stent is already marketed in multiple countries within Europe, Middle East & Africa.