Avinger Announces New FDA Clearance for Lumivascular Imaging Console, Enabling Vessel Measurement Via Touchscreen

Technology Upgrade to Lightbox L250 Allows Physicians to Accurately Assess Luminal Gain

Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced that the company has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lightbox L250 imaging console. With this new FDA clearance, the Lightbox L250 now provides detailed measurement of vessels with a few simple taps to a touch screen, helping further improve visualization inside the vessel before, during, and after Pantheris™ Lumivascular atherectomy procedures for the treatment of PAD.

In addition, this enhanced technology allows the clinician to create borders and measurements in seconds to determine the area of any vessel feature, automatically generate minimum and maximum diameters within a given area, and generate vessel size measurements for reference vessel sizing to facilitate adjunctive therapies. Users can easily add and move reference points for even greater control.

“The ability to obtain an accurate and real-time measurement from inside a diseased vessel is vital – it provides us key pieces of information that we can use to determine the levels of stenosis and luminal gain both during and immediately after an atherectomy procedure,” said Sean Janzer, M.D., interventional cardiologist from Einstein Medical Center in Philadelphia, Pa. “Additionally, the measurements made possible by this latest upgrade will help optimize both the atherectomy and adjunctive therapies performed post-atherectomy, such as the deployment of a drug-coated balloon or placement of a stent.”

“We are excited to announce this latest FDA clearance, which greatly enhances the ability of the Lightbox L250 to accurately provide vessel measurements, further advancing the potential of Lumivascular technology to dramatically improve patient care,” said John B. Simpson, Ph.D., M.D., Avinger’s founder and executive chairman. “Achievement of this FDA clearance is a key step in our ongoing commitment to ensuring our users have the latest technological advancements at their fingertips for greater confidence and control in treating patients with PAD.”

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, which 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, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.

The new software will be made available to all existing L250 users at no cost and will be incorporated in all future Lightbox products as part of the standard software packages.

About Avinger, Inc.

Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided catheter-based systems for the treatment of patients with peripheral artery disease (PAD). PAD is characterized by a build-up of plaque in the arteries that supply blood to the arms and legs. The company’s mission is to dramatically improve the treatment of vascular disease through the introduction of products based on its Lumivascular platform, the only intravascular image-guided system of therapeutic catheters available in this market. Avinger’s current Lumivascular products include the Lightbox imaging console, the Ocelot family of catheters, which are designed to penetrate total arterial blockages, known as chronic total occlusions, or CTOs, and Pantheris™, the first-ever image-guided atherectomy device, designed to precisely remove arterial plaque in PAD patients. For more information, please visit www.avinger.com.

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