According to Tryton Medical, results from the Tryton Confirmatory Study confirm the acceptable acute safety profile of the Tryton side-branch stent for the treatment of coronary bifurcation lesions in vessels appropriate for a ≥2.5mm stent. These results were presented yesterday at TCT.
The Tryton Confirmatory Study (single-arm clinical trial, n=133) was designed to validate the acute safety profile of the Tryton side-branch Stent shown in a post hoc analysis of the Tryton randomised controlled trial (n=704). The post hoc analysis showed that the Tryton side-branch stent reduced target vessel failure and improved side-branch percent diameter stenosis when compared with provisional stenting in the intended treatment population (appropriate for a ≥2.5mm stent). The Tryton Confirmatory Study showed a periprocedural myocardial infarction rate (primary endpoint) meeting the pre-established performance goal, set based on the rate of the provisional control arm observed in the Tryton RCT.
Principal investigator Martin B Leon (director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital, USA), says: “These findings provide strong clinical evidence demonstrating that the Tryton side-branch stent provides predictability and durability when treating coronary bifurcation lesions with significant side branches, while preserving main vessel results. With an established safety profile, Tryton has the potential to disrupt standard strategies for treating complex bifurcation lesions.”
Tryton reports that the results from the post hoc analysis of the Tryton randomised controlled trial and the data from the Tryton Confirmatory Study will be used to support Tryton’s Premarket Approval (PMA) application for Tryton side-branch stent to the FDA in the coming weeks.