Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced today that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its next generation Pantheris® Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of peripheral artery disease. Lumivascular is the only technology that combines real-time intravascular imaging with highly effective catheters for the treatment of PAD. Peripheral artery disease is projected to affect more than 21 million people in the United States alone by 2020.

The new version of Pantheris received CE Marking approval in December 2017, and patients have been successfully treated with this new device in Germany since that time.  Avinger’s next generation Pantheris device includes a number of design improvements, including a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a reinforced nosecone with the option for more tissue storage capacity, and an enhanced cutter design. The Company intends to launch two versions of this product (standard and extended length nosecone) into initial sites in the U.S. immediately, and plans to incorporate the new design into the INSIGHT IDE clinical trial currently in progress. INSIGHT is a multi-center clinical study designed to evaluate the safety and effectiveness of Pantheris for treating in-stent restenosis (ISR) in lower extremity arteries. Distribution of the next generation Pantheris will be expanded as the Company increases production and gains purchasing approvals in additional Lumivascular sites.

“We are excited to introduce the next generation Pantheris to our network of physicians here in the United States,” said Mr. Jeff Soinski, Avinger’s President and CEO. “After extensive testing by our R&D and operations teams, physician design validation, and successful initial case experience in Europe across a variety of different lesion types, we believe this next generation device will significantly improve the user experience in terms of reliability, efficiency, and ease of use across a spectrum of clinical situations.”

Dr. Barry Tedder, M.D., Interventional Cardiologist at St. Bernards Medical Center in Jonesboro, Arkansas, commented, “The Pantheris Lumivascular atherectomy system has allowed me to treat peripheral artery disease with more precision while largely avoiding trauma to the blood vessel during an intervention. Unlike some other products, this technology’s performance can stand on its own but also enhance other forms of adjunctive therapy if needed, while preserving future treatment options for the patient. As one of the first users of the initial generations of Pantheris, I have been eagerly awaiting the product enhancements incorporated into the new system, which has the promise of not only improving ease of use, but also providing a new level of operator control during the procedure.”

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 an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger’s proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions 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.