Avinger Completes Enrollment for SCAN Study Comparing OCT With IVUS as Diagnostic Imaging Tool

August 23, 2018—Avinger, Inc. announced that it has concluded enrollment in the company’s SCAN clinical study. According to the company’s announcement, the SCAN study is a postmarket study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as a diagnostic imaging tool in the peripheral arteries.

The SCAN study aimed to collect at least 115 matched images using OCT and IVUS from up to 20 patients at two centers in the United States. With enrollment complete, the study has exceeded 115 matched OCT and IVUS images captured at identical positions within vessel segments from 14 patients diagnosed with peripheral artery disease (PAD).

The images will be reviewed and ranked for clarity to identify vessel morphology (eg, the components of vessel wall layers, bifurcation), abnormal physiology (eg, plaque, dissection, thrombus, calcium), and artifacts by three independent radiologists. Additionally, vessel measurement from each imaging modality will be compared.

Avinger’s Lumivascular platform includes the FDA-approved Pantheris and Ocelot image-guided catheters for atherectomy and chronic total occlusion crossing, respectively. This proprietary technology utilizes OCT to provide real-time vascular imaging for the diagnosis and treatment of PAD.

Additionally, the company commented in its press release that the SCAN study results will support an initiative to gain incremental reimbursement for OCT diagnostic imaging in the peripheral arteries similar to the existing reimbursement available for the use of IVUS as a diagnostic tool. Reimbursement codes for the Pantheris and Ocelot image-guided catheters already exist for therapeutic peripheral interventions.

Avinger anticipates releasing final data once results are available and they will be submitted for publication by the primary investigators, Edward Pavillard, MD, a vascular surgeon at PA Vascular Institute in King of Prussia, Pennsylvania, and Luke Sewall, MD, an interventional radiologist and President of Vascular and Interventional Professionals in Hinsdale, Illinois.