Tryton Medical, Inc., specialist in stents designed to treat bifurcation lesions, has gained CE Mark approval for its Tryton Side Branch SHORT Stent, a novel coronary stent system that broadens the treatment options in bifurcations in large vessels with a short main branch landing zone. The company is launching the product immediately in CE Mark countries and showcases it at EuroPCR 2013 in Paris
The Tryton Side Branch Stent System is built for bifurcation 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 newly approved Tryton Side Branch SHORT Stent length is 15 mm, or 3mm shorter in the main branch zone than the standard Tryton Side Branch Stent. This innovation leverages the company’s proprietary, first-in-class Tri-ZONE® technology and adds to the Tryton family of stents.
The Tryton Side Branch SHORT Stent is supported by what the company press release refers to as robust clinical evidence of the Tryton Side Branch Stent. Published data from more than 1,000 patients treated with the Tryton Side Branch Stent in more than 8 European post-marketing registries demonstrated low target lesion revascularization rates of 2.9 percent at six months and 4.0 percent at one year, and a low 0.5 percent thrombosis rate at one year. More than 7,500 patients have been treated with the Tryton Side Branch Stent and it is commercially available throughout Europe, Russia and the Middle East.
Joanna J. Wykrzykowska, M.D., Ph.D., from the Academic Medical Center, University of Amsterdam, Netherlands completed the first implant of the Tryton Side Branch SHORT Stent. “The Tryton Side Branch SHORT Stent is an important advance in coronary stents. It gives me the control I need to treat patients who present with significant disease in a large, bifurcated vessel and whose anatomy in the main branch makes it challenging to deliver a longer size stent,” said Dr. Wykrzykowska.
Dr. Wykrzykowska continued, “The Tryton Side Branch SHORT Stent may be particularly helpful when treating disease in the left main artery. Left main coronary artery disease has historically been challenging to address interventionally, but this new stent provides confidence I can deliver it where it needs to go and ensure both the main branch and side branch openings receive optimum scaffolding and support.”
“Interventional cardiologists told us they would value a dedicated bifurcation stent designed to work in their more challenging patients. The Tryton Side Branch SHORT Stent was developed in response to this request,” said Shawn McCarthy, CEO of Tryton Medical. “We are pleased we were able to quickly and effectively iterate our stent design, secure regulatory approval and bring doctors the confidence and control they expect from Tryton, optimized for more complex bifurcations.”
The Tryton Side Branch Stent is an investigational device in the United States. Tryton has completed enrollment in the first and only randomized controlled U.S. IDE pivotal clinical trial evaluating a dedicated bifurcation stent and anticipates study outcomes will be presented at TCT 2013 in San Francisco.
Source: Tryton Medical, Inc., Business Wire