Business Wire07.06.16
Tryton Medical Inc., a developer of stents designed to treat coronary bifurcation lesions, said its Tryton Confirmatory Study results confirm the safety profile for treatment of coronary bifurcation lesions involving large side branches.
The study, designed to confirm the safety and efficacy of the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches (appropriate for a ≥2.5 millimeter stent), compared 133 patients treated with the Tryton stent to a performance goal based on performance of the control arm from the Tryton Randomized Controlled Trial (RCT). The study met its pre-specified primary endpoint, periprocedural myocardial infarction, which was within its non-inferiority margin (Primary Endpoint: 10.5 percent plus 95 percent C.I. vs. 17.9 percent, p=0.01).
“In light of the higher procedural success rate, improved acute angiographic results, and higher rate of side branch patency at nine months compared to provisional stenting, the Tryton Confirmatory Study and the Tryton RCT support the use of the dedicated bifurcation Tryton stent,” said principal investigator Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital, in New York, N.Y.
Results from the Tryton RCT and the Tryton Confirmatory Study have been submitted to the U.S. Food and Drug Administration (FDA) to support the company's premarket approval application for the Tryton Side Branch Stent.
Watch the video below to learn how the Tryton Side Branch Stent is deployed:
“Bifurcation lesions are a common challenge for interventional cardiologists, present in 20 percent to 30 percent of coronary lesions treated with percutaneous coronary intervention,” said Shawn P. McCarthy, president and CEO of Tryton Medical. “Providing cardiologists both ease of use and procedural control results in predictable outcomes, and our pivotal trial demonstrated superior acute device success and long-term patency over provisional stenting. We’re continuing to work closely with FDA through the final stages of regulatory review.”
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. Tryton Side Branch Stent has now been used to treat more than 12,000 patients worldwide. The Tryton Side Branch Stent is commercially available in multiple countries within Europe, Middle East and Africa, is investigational in the United States, and is not available in Japan.
Tryton Medical, located in Durham, N.C., develops stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D., professor of medicine at the Geisel School of Medicine/Dartmouth-Hitchcock Medical Center, to develop stents for the definitive treatment of bifurcation lesions.
The study, designed to confirm the safety and efficacy of the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches (appropriate for a ≥2.5 millimeter stent), compared 133 patients treated with the Tryton stent to a performance goal based on performance of the control arm from the Tryton Randomized Controlled Trial (RCT). The study met its pre-specified primary endpoint, periprocedural myocardial infarction, which was within its non-inferiority margin (Primary Endpoint: 10.5 percent plus 95 percent C.I. vs. 17.9 percent, p=0.01).
“In light of the higher procedural success rate, improved acute angiographic results, and higher rate of side branch patency at nine months compared to provisional stenting, the Tryton Confirmatory Study and the Tryton RCT support the use of the dedicated bifurcation Tryton stent,” said principal investigator Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital, in New York, N.Y.
Results from the Tryton RCT and the Tryton Confirmatory Study have been submitted to the U.S. Food and Drug Administration (FDA) to support the company's premarket approval application for the Tryton Side Branch Stent.
Watch the video below to learn how the Tryton Side Branch Stent is deployed:
“Bifurcation lesions are a common challenge for interventional cardiologists, present in 20 percent to 30 percent of coronary lesions treated with percutaneous coronary intervention,” said Shawn P. McCarthy, president and CEO of Tryton Medical. “Providing cardiologists both ease of use and procedural control results in predictable outcomes, and our pivotal trial demonstrated superior acute device success and long-term patency over provisional stenting. We’re continuing to work closely with FDA through the final stages of regulatory review.”
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. Tryton Side Branch Stent has now been used to treat more than 12,000 patients worldwide. The Tryton Side Branch Stent is commercially available in multiple countries within Europe, Middle East and Africa, is investigational in the United States, and is not available in Japan.
Tryton Medical, located in Durham, N.C., develops stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D., professor of medicine at the Geisel School of Medicine/Dartmouth-Hitchcock Medical Center, to develop stents for the definitive treatment of bifurcation lesions.