FDA Approves Pivotal Study of Tryton's Side Branch Stent

December 2, 2010—Tryton Medical, Inc. (Durham, NC) announced US Food and Drug Administration conditional approval for an investigational device exemption application to initiate a pivotal trial that will evaluate the company's side branch stent system for treating coronary artery disease. Martin B. Leon, MD, will serve as principal investigator of the study. 

According to the company, 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 versus 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 9 months. A secondary endpoint is the percent diameter stenosis at 9 months in the side branch vessel as assessed in an angiographic subgroup.

Approximately 374 patients will undergo angiographic follow-up at 9 months. The study will also include an intravenous ultrasound substudy in 96 patients, with follow-up at 9 months. The study will enroll 704 patients at up to 75 centers in North America and Europe.



The company stated that the Tryton side branch stent system is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. The 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 stent system has received CE Mark approval in Europe and is commercially available in Europe and the Middle East. It is not approved in the United States, the company advised. 

On December 20, Tryton announced that the first patient has been enrolled in the pivotal trial to evaluate the Tryton side branch stent system for the treatment of coronary artery disease.