Indication Expanded for Avinger's Pantheris Lumivascular Atherectomy System

October 19, 2016—Avinger, Inc. announced that it has received expanded indications from the US Food and Drug Administration (FDA), which now recognizes the company's Pantheris Lumivascular atherectomy system as a technology that can be used for both therapeutic and diagnostic purposes in peripheral artery disease (PAD). 

According to Avinger, the image-guided atherectomy device is cleared for diagnostic imaging as well as for the simultaneous treatment of PAD. This expanded indication clarifies that, in addition to treatment of PAD, Pantheris may be used by physicians to identify the vessel lumen and wall structures, such as intima, internal elastic lamina, media, external elastic lamina, and stent struts, as well as vessel morphologies, such as calcium, thrombus, fibroatheromas, and necrotic cores.

The company noted that the Lumivascular technology in the Pantheris catheter allows physicians to see from inside the artery during a directional atherectomy procedure by using optical coherence tomography (OCT), allowing accurate navigation of devices to treat PAD lesions. Additionally, by relying upon OCT images as an adjunct to fluoroscopy, exposure to ionizing radiation may be reduced for health care workers and patients.

In Avinger’s press release, Suhail Dohad, MD, commented, “The FDA clearance of Pantheris as a diagnostic tool reflects what we as clinicians have already seen firsthand in our practices: that Pantheris OCT images provide important clinical information during our procedures, allowing us to see complicated plaque characteristics in real time as we treat the vessel. With Pantheris, we can now reliably assess disease extent while simultaneously treating disease, allowing a greater level of accuracy and confidence.” Dr. Dohad is an interventional cardiologist with Cedars Sinai Hospital in Los Angeles, California.