Avinger (AVGR) Receives Expanded FDA Indications for Pantheris LA System

October 19, 2016 4:03 PM EDT

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Avinger, Inc. (Nasdaq: AVGR) announced that the company has received expanded indications from the U.S. Food and Drug Administration (FDA) recognizing the Pantheris™ Lumivascular atherectomy system as a technology that can be used for both therapeutic and diagnostic purposes.

Pantheris is the first and only image-guided atherectomy device to receive clearance 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 (IEL), media, external elastic lamina (EEL) and stent struts, as well as vessel morphologies such as calcium, thrombus, fibroatheromas, and necrotic cores.

“I am thrilled that Pantheris is now recognized as providing important diagnostic imaging information that enhances physicians’ ability to deliver the most advanced treatments for vascular disease,” said John B. Simpson, Ph.D., M.D., the company’s founder and executive chairman. “This is one more step toward establishing Lumivascular technology as a premier interventional platform for physicians.”

Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology in the Pantheris catheter allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT. In the past, physicians have had to rely solely on X-ray as well as touch and feel to guide their tools while they try to treat complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices to treat PAD lesions using the guidance of OCT images generated from inside the artery. By relying upon OCT images as an adjunct to fluoroscopy, exposure to ionizing radiation may be reduced for healthcare workers and patients.

“The FDA clearance of Pantheris as a diagnostic tool reflects what we as clinicians have already seen first-hand 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,” said Suhail Dohad, M.D., interventional cardiologist with Cedars Sinai Hospital, Los Angeles, Calif. “With Pantheris, we can now reliably assess disease extent while simultaneously treating disease, allowing a greater level of accuracy and confidence.”



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