Stent systems developer Tryton Medical has obtained the US Food and Drug Administration (FDA) premarket approval (PMA) for its Tryton Side Branch Stent to treat coronary bifurcation lesions involving large side branches.
Equipped with the Tri-ZONE technology, Tryton Side Branch Stent system is made of cobalt chromium and is deployed in the side branch artery utilising single wire balloon-expandable stent delivery system.
Compatible with any conventional drug eluting stent in the main vessel, the device comes in different diameters such as 2.5mm to 3.5mm in the side branch.
Tryton Medical president and chief executive officer Shawn McCarthy said: “With this first-of-its-kind approval in the US, interventional cardiologists now have access to a stent that is specifically engineered to provide the complete lesion coverage and more predictable patient outcomes needed for the challenging anatomy of coronary bifurcation lesions.”
A randomised investigational device exemption (IDE) clinical trial conducted to evaluate the stent indicated that it has decreased the need for additional bailout stenting, during a post hoc analysis.
The study also found that the stent led to statistically lower side branch percent diameter stenosis at nine month follow up and showed comparable major adverse cardiovascular events (MACE) and myocardial infarction (MI) rates at three years.
The firm has signed a strategic distribution agreement with Cardinal Health, under which its interventional vascular business Cordis will exclusively distribute the stent in the US
Used to treat more than 12,000 patients till date, the stent is available in several countries across Europe, the Middle East and Africa.