News | Stents Bifurcation | October 14, 2015

Tryton Side Branch Stent Meets Primary Endpoint in Pivotal Confirmatory Study

Positive results presented at Transcatheter Cardiovascular Therapeutics symposium support planned PMA submission

Tryton Confirmatory Study, Side Branch Stent, TCT 2015, bifurcation lesions

Image courtesy of Tryton Medical

October 14, 2015 — Tryton Medical Inc. announced results from the pivotal Tryton Confirmatory Study confirming 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. Results were presented as part of the Featured Clinical Research session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF) being held in San Francisco, California.

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 Randomized Clinical Trial (RCT, n=704). The post hoc analysis of the Tryton RCT showed the device 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 (PPMI) rate (primary endpoint) meeting the pre-established performance goal, set based on the PPMI rate of the provisional control arm observed in the Tryton RCT.

Results from the post hoc analysis of the Tryton RCT 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 U.S. Food and Drug Administration in the coming weeks.

“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,” said principal investigator Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital. “With an established safety profile, Tryton has the potential to disrupt standard strategies for treating complex bifurcation lesions.”

The Tryton Side Branch Stent System is built using proprietary Tri-Zone technology to offer a dedicated strategy for treating bifurcation lesions. Tryton’s cobalt chromium stent is deployed in the side branch artery using a standard single wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.

The device is commercially available in multiple countries within Europe, Middle East & Africa, is investigational in the United States and is not available in Japan.

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