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.

For more information: www.trytonmedical.com

Related Content

Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
Overlay Init