FDA approves IDE application to initiate Tryton Side Branch Stent System for coronary artery disease

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced U.S. Food and Drug Administration (FDA) conditional approval for an Investigational Device Exemption (IDE) application to initiate the pivotal trial to evaluate the Tryton Side Branch Stent System™ for the treatment of coronary artery disease.

“There is a significant need for alternative solutions for treating bifurcation disease, a persistent and challenging problem for interventional cardiologists that occurs frequently - in about two out of ten cases”

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.

Martin B. Leon, M.D., professor of Medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, and founder and chairman emeritus of the Cardiovascular Research Foundation, will serve as principal investigator of the study.

"There is a significant need for alternative solutions for treating bifurcation disease, a persistent and challenging problem for interventional cardiologists that occurs frequently - in about two out of ten cases," said Dr. Leon. "Data from previous studies of the Tryton solution have been highly encouraging, and I look forward to results from this important trial."

"The conditional approval of the investigational device exemption for the Tryton stent is a significant milestone for our company," said J. Greg Davis, president and CEO of Tryton Medical. "We have seen substantial interest and adoption of the Tryton solution in Europe thus far and are excited to take the first step to bring this innovative treatment to patients and physicians in the United States."

The randomized, controlled study will compare the use of the Tryton stent in the side branch in conjunction with a standard drug eluting stent in the main vessel vs. the use of angioplasty in the side branch with a standard drug eluting stent in the main vessel for the treatment of complex bifurcation disease. The primary endpoint of the study is target vessel failure at nine months. A secondary endpoint is percent diameter stenosis at nine months in the side branch vessel as assessed in an angiographic subgroup. Approximately 374 patients will undergo angiographic follow up at nine months. The study will also include an IVUS substudy in 96 patients with IVUS follow up at nine months. The study will enroll 700 patients at up to 75 centers in North America and Europe.