Tryton Medical and Cardinal Health have announced that they have established a long-term strategic agreement for US distribution of the Tryton side-branch stent, pending regulatory approval. Tryton submitted a pre-market approval (PMA) application to the FDA for the Tryton side-Branch Stent in November 2015. If approved, the Tryton side-branch stent would be the first stent specifically indicated for the treatment of bifurcation lesions in the USA.
Shawn McCarthy, president and chief executive officer of Tryton Medical comments: “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 USA, 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.”
“In extensive clinical research, the Tryton side-branch stent has demonstrated an ability to provide predictability and durability when treating coronary bifurcation lesions with significant side branches. This uniquely engineered stent has the potential to disrupt standard strategies for treating complex bifurcation lesions,” Martin Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital, says.