Two U.S. imaging centers initiated the postmarket study in June 2018 and currently have more than 115 matched images generated by OCT and IVUS at identical positions within vessel segments from 14 subjects.
Researchers will assess Avinger's Lumivascular technology, which utilizes OCT for real-time vascular imaging for the diagnosis and treatment of peripheral artery disease. OCT generates no x-ray radiation and produces images at a resolution approximately 10 times greater than that of IVUS.
The U.S. Food and Drug Administration (FDA) has cleared both diagnostic and therapeutic treatment indications for Avinger's Pantheris and Ocelot image-guided catheters.
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