Tryton Medical, a developer of stents designed to definitively treat bifurcation lesions, has enrolled first patient in the pivotal trial to evaluate the Side Branch Stent System for the treatment of coronary artery disease.
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 study will enroll 704 patients at up to 75 centers in North America and Europe.
The primary endpoint of the study is target vessel failure at nine months and the secondary endpoint is percent diameter stenosis at nine months in the side branch vessel as assessed in an angiographic subgroup.
Tryton Medical president and CEO Greg Davis said the enrollment of the first patient in the study is yet another milestone for Tryton in what has been a very exciting year for the company.
"We have gained significant momentum in 2010 from launching our innovative product across Europe and the Middle East to a successful fundraising event. We look forward to rapid enrollment in the pivotal study and growing product adoption internationally in 2011," Davis said.