Tryton Medical Announces CE Mark and European Launch of Next-Generation Tryton Side Branch SHORT Stent

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, today announced that the company received the CE Mark for the 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 Tryton Side Branch SHORT Stent length is 15 mm, or 3mm shorter in the main branch zone than the standard Tryton Side Branch Stent. The company is launching the product immediately in CE Mark countries. This innovation leverages the company’s proprietary, first-in-class Tri-ZONE® technology and adds to the Tryton family of stents.

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.”

The company will launch the Tryton Side Branch SHORT Stent during EuroPCR 2013 in Paris at their exhibitor booth #M27.

“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 SHORT Stent is supported by the 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.

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.

About Coronary Bifurcation Disease

Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. In patients undergoing PCI-stenting, approximately one-third have a bifurcation lesion. Left main disease, an accumulation of plaque that narrows the base of the coronary tree, is a persistent challenge in interventional cardiology, as more than 75 percent of left main lesions are bifurcation lesions. The Tryton Side Branch Stent has not been studied extensively in left main disease.

About the Tryton Side Branch Stent System

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.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Durham, N.C., is the leading developer of novel stent systems for the treatment of bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of medicine at Dartmouth Medical School/Dartmouth-Hitchcock Medical Center) and Dan Cole of Spray Venture Partners to develop stents for the definitive treatment of bifurcation lesions. Privately held, Tryton is backed by PTV Sciences, RiverVest Venture Partners, Spray Venture Partners, and the 3×5 Special Opportunity Fund. For more information please visit trytonmedical.com and follow the company on Twitter at @TrytonMedical1.