Avinger Receives CE Marking Approval for In-Stent Restenosis Treatment Indication With Pantheris Image-Guided Atherectomy

Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the Pantheris® Lumivascular atherectomy system.

In-stent restenosis occurs when a previously blocked artery treated with a stent becomes narrowed again, blocking blood flow. Physicians often face challenges when treating in-stent restenosis both in terms of safety and efficacy. From a safety standpoint, limitations in imaging techniques such as X-ray fluoroscopy and the inability to control the directionality of other treatment modalities’ mechanism of action creates the concern of potentially impacting the integrity of the stent during the intervention. In terms of efficacy, current therapies for in-stent restenosis such as balloon angioplasty suffer from high rates of recurrent renarrowing within stents. 

“The demand for improved treatment options for in-stent restenosis is growing as physicians experience the accurate visualization and precision provided by state-of-the-art technologies such as the Pantheris Lumivascular atherectomy system,” said Jeff Soinski, Avinger’s president and CEO. “CE Marking for this particular indication is an important milestone for Avinger that addresses an area of unmet clinical need for patients suffering from PAD. Onboard image guidance coupled with directional plaque excision offers the interventionist clear benefits when treating in-stent restenosis and represents another opportunity to improve patient outcomes.”

“Two elements thoughtful interventionists want to avoid during intervention are adventitia and stent struts,” said John B. Simpson, Ph.D., M.D., founder and executive chairman. “Intravascular visualization combined with a directional mechanism in real time provides operators the information and precision needed to treat only diseased tissue without coming into contact with the stent struts or adventitia.” 

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 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, that is displayed on the Lightbox console. In the past, physicians have had to rely solely on X-ray as well as tactile feedback to guide their tools while treating complicated arterial disease. With the Lumivascular approach using real-time OCT image guidance, physicians can more accurately navigate their devices to treat PAD without exposing healthcare workers and patients to the negative effects of ionizing radiation. 

About Avinger, Inc.

Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, CA. For more information, please visit www.avinger.com.

Public Relations Contact:Phil PreussVP of Marketing & Business OperationsAvinger, Inc.(650) [e-mail]

Investor Contact:Matt FergusonChief Business Officer & CFOAvinger, Inc.(650) [e-mail]