Avinger enrolls first patients in post-market study comparing OCT with IVUS
Avinger announced the initiation of the SCAN study, a post-market study comparing optical coherence tomography, or OCT, with intravascular ultrasound, or IVUS, as a diagnostic imaging tool in the peripheral arteries. OCT is a light-based, high definition imaging modality, which generates no X-ray radiation. Avinger's proprietary Lumivascular technology utilizes OCT to provide real-time intravascular imaging during the treatment of peripheral artery disease. The Company's Pantheris image-guided atherectomy and Ocelot image-guided chronic total occlusion, or CTO, crossing catheters are the only catheters available worldwide that incorporate the additional benefits of real-time intravascular imaging during PAD treatment. While the FDA has already cleared OCT diagnostic claims for Avinger's Pantheris and Ocelot catheters, and reimbursement codes applicable to therapeutic peripheral interventions with the Company's Lumivascular catheters already exist, the results of the SCAN study are intended to support an initiative to gain incremental reimbursement for OCT diagnostic imaging in the peripheral arteries similar to the reimbursement currently provided for the use of IVUS in this setting. The study will enroll up to 20 subjects diagnosed with peripheral artery disease at two centers in the United States, with the goal to acquire at least 115 matched images generated by OCT and IVUS imaging for analysis. More specifically, OCT and IVUS images will be captured at identical positions within vessel segments so that a comparison can be made between the two imaging modalities. Dr. Edward Pavillard, a vascular surgeon at PA Vascular Institute, and Dr. Luke Sewall, an interventional radiologist and president of Vascular and Interventional Professionals, will serve as physician investigators in this study. Dr. Suhail Dohad, an interventional cardiologist in Los Angeles, will also serve as an advisor to the study.