In November 2015, a pre-market approval (PMA) application was submitted to the US Food and Drug Administration (FDA) for the Tryton Side Branch Stent.
Tryton Side Branch Stent will be the first stent to treat bifurcation lesions in the US, if approved.
Developed by using Tri-ZONE technology, the Tryton’s cobalt chromium stent will be deployed in the side branch arter using a standard single wire balloon-expandable stent delivery system.
Later, the conventional drug eluting stent will be placed in the main vessel.
Currently, the stent delivery system is available in different countries in the Europe, Middle East and Africa. It is not available in the US and Japan.
Tryton Medical president and CEO Shawn McCarthy said: “Bifurcation disease is one of the most significant unmet needs in interventional cardiology. The current practice of provisional stenting typically involves complex procedures with uncertain results.
“Tryton is committed to providing physicians a predictable treatment strategy for bifurcation lesions based on an easy to use solution for any anatomical challenge.
“Pending our regulatory approval in the U.S., we are excited to collaborate with Cordis, Cardinal Health’s interventional vascular business, to achieve our goal of establishing a new standard of care with a definitive treatment for complex bifurcation disease.”
Based in Durham of North Carolina, Tryton Medical is engaged in the development of advanced stent systems for the treatment of bifurcation lesions.
