Avinger Announces Preliminary Analysis of SCAN Results

 

December 19, 2018—Avinger, Inc. announced the release of a preliminary analysis of results from SCAN, its postmarket clinical study comparing optical coherence tomography (OCT) with intravascular ultrasound (IVUS) as diagnostic imaging tools in the peripheral arteries. Initial analysis of the SCAN data indicated that OCT imaging with Avinger’s Pantheris system showed statistical superiority or equivalence to IVUS on all parameters evaluated. In August, Avinger announced completion of enrollment in the SCAN study.

Investigators in the SCAN study captured 120 OCT and IVUS matched images (240 images in total) at identical positions within vessel segments from 12 patients at two clinical centers. Then, three independent radiologists reviewed the matched images and ranked them in terms of image quality and ability to display vessel morphology and disease. Vessel measurement capabilities were also compared between the two imaging modalities.

According to Avinger, the preliminary data analysis from the reviewer rankings of the 240 images indicated that OCT imaging with Pantheris was significantly better than IVUS in terms of visualizing plaque, calcification, and stent struts. OCT imaging was ranked to be statistically equivalent to IVUS in visualizing the layered structures of the vessel wall and visualizing troughs following atherectomy. Vessel measurement and interference of artifacts with imaging quality were also statistically equivalent between the two imaging modalities.

The final SCAN study results are expected to be submitted for publication by its physician 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.

Dr. Pavillard commented, “The SCAN study does an excellent job demonstrating the clinical value of intravascular imaging with OCT and IVUS for the diagnosis of peripheral arterial disease. While OCT performed better on certain parameters, what is paramount to providing excellent clinical results is the capability to see what is present in the vessel so that diseased tissue can be removed without causing injury to healthy tissue. To our knowledge, SCAN is only the second study in the world and the first United States–based study comparing OCT with IVUS intravascular imaging in the peripheral vessels. We look forward to sharing more detailed findings of the study as they become available.”

The FDA has cleared both diagnostic and therapeutic treatment indications for use for Avinger’s Pantheris atherectomy and Ocelot CTO-crossing image-guided catheters.

The company noted that although reimbursement codes applicable to therapeutic peripheral interventions with its image-guided 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 as a diagnostic tool in this setting.

 

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