Tryton Medical Introduces Physician Education Program

DURHAM, N.C.–(BUSINESS WIRE)–Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, today announced it has introduced a physician education program, starting with the Tryton Bifurcation Case of the Month.

The Tryton Bifurcation Case of the Month series highlights physician review and analysis of a patient case that employed dedicated bifurcation stenting. The first case, provided by Dr. Michael A. Kutcher of Wake Forest Baptist Medical Center in Winston-Salem, North Carolina, features a patient enrolled in the Tryton Side Branch Stent clinical study. Tryton Medical 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 later this year at TCT 2013 in San Francisco.

“Bifurcation lesions are always complex and even more so when they are diffuse. Treatment of these lesions in a provisional treatment strategy is unpredictable and in most cases incomplete,” said Dr. Kutcher. “The use of the Tryton Side Branch Stent definitively treats the entire bifurcation with a few controlled steps, changing the complex into a straight forward case.”

The Tryton Bifurcation Case of the Month is the company’s latest program to support the investigation, education and treatment of bifurcated coronary artery disease.

“The new Case of the Month series is the result of discussions with clinicians worldwide who expressed great interest in education steeped in real-world experience. We are pleased to bring forward this program, as it reflects our commitment to gold-standard education,” said Shawn McCarthy, CEO of Tryton Medical. “Tryton Medical has made the most significant investments in the world to help advance the treatment of bifurcated coronary artery disease. Beyond the randomized study evaluating the Tryton Side Branch Stent, we’ve studied more than a thousand patients in clinical registries with our physician partners, and just recently announced our involvement in the Nordic-Baltic Dedicated Bifurcation Trial scheduled to begin enrolling later this year.”

The Tryton Side Branch Stent is supported by robust clinical evidence in more than 1,000 patients. Published data in June 2013 edition of EuroIntervention reports a patient pooled analysis from more than 900 patients treated with the Tryton Side Branch Stent in more than 8 European post-marketing registries. The data demonstrated low clinically indicated 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 SHORT Stent was introduced earlier this year at EuroPCR 2013, enabling physicians to broaden treatment options in bifurcations in large vessels with a short main branch landing zone.

The Tryton Side Branch Stent is an investigational device in the United States.

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. 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.