FDA approves Tryton Side Branch Stent for the treatment of coronary bifurcation lesions.-Tryton Medical, Inc.

Tryton Medical, Inc., the leading developer of stents designed to treat coronary bifurcation lesions, announced the FDA has approved the company�s Premarket Approval (PMA) application for the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches (appropriate for a more than 2.5mm stent). The Tryton Side Branch Stent is the first dedicated bifurcation device to receive regulatory approval in the U.S.

Coronary artery disease (CAD), the leading cause of death in the U.S. in both men and women, often results in the buildup of plaque at a site where one artery branches from another, also known as a bifurcation. Approximately 20-30% of all patients undergoing percutaneous coronary interventions (PCI) to open blocked arteries have a bifurcation lesion. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.