"This data demonstrates that the Spy system identified major graft problems that would otherwise have gone unrecognized in 4 percent of the patients operated on in this study. Another 4 percent of patients had minor graft revisions based on the Spy system images", stated Dr. Desai. "Given the increasing anatomic complexity of contemporary coronary bypass patients, this system provides a significant advance in assuring the quality of coronary bypass surgery. Failure of bypass grafts during coronary bypass surgery is an underappreciated problem. With this imaging technology, patients can be assured that their heart operation was truly successful."
Intra-operative graft angiography with the Spy system involves intravascular administration of fluorescent indocyanine green dye (ICG) and visualization of the graft with dispersed laser light. In this study, 336 bypass grafts in 120 patients were examined using the Spy system and a small subset of these grafts were also examined by x-ray angiography. The Spy system was demonstrated to be a simple and highly reproducible procedure. The authors found that there was excellent agreement between independent evaluations of graft patency (94 percent agreement) and need for graft revision (100 percent agreement). Pilot data also suggested that the Spy system provided similar quality images to traditional x-ray angiography, a much more invasive procedure.
Novadaq's Spy intra-operative imaging system has received 510(k) clearance from the United States Food and Drug Administration (FDA) for use during CABG surgery. Spy is the first intra-operative fluorescent imaging system that enables cardiac surgeons to confirm the location of the coronary arteries and assess bypass graft functionality during coronary artery bypass procedures. The Spy system enables the surgeon to view, record, replay, print and archive high quality real-time images of the coronary arteries and bypass grafts.
Novadaq is focused on developing and marketing diagnostic and therapeutic medical devices for vascular imaging. Novadaq's Spy system fulfils the unmet need of validating a successful revascularization during CABG surgery. Novadaq's ophthalmic product is aimed at the diagnosis and treatment of wet Age Related Macular Degeneration (AMD) by using the same core imaging technology that is used in the Spy intra-operative imaging system.