For all the success that drug-eluting stents (DES) have had in treating restenosis (late-stent thrombosis safety issues notwithstanding), certain types of vascular disease remain challenges for interventional cardiologists, even with the current-generation of DES. These include chronic total occlusions, and small and tortuous diseased vessels. One of the largest areas of unmet clinical need exists in patients with bifurcated lesions, where restenosis occurs at a point at which vessels divide into a Y-shape, with a side branch that is more than 2 mm in diameter coming off the main vessel.
Bifurcated lesions occur in an estimated 20 to 30% of all percutaneous coronary interventions (PCI). They are currently treated largely...