REDWOOD CITY, CA / September 5, 2018 / Avinger, Inc. (AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that physicians in 35 sites globally have successfully treated over 200 patients with the next-generation Pantheris image-guided atherectomy system for the treatment of peripheral artery disease (PAD).

The next-generation Pantheris was launched on a limited basis in the U.S. following receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) in late May 2018. The next-generation Pantheris device features a number of improvements intended to augment the performance and reliability of the design, including a simplified single balloon system for cutter apposition and blood flow management, a stiffer shaft for increased pushability, a more robust nosecone with the option for more tissue storage capacity, and an enhanced cutter design. Clinical results with the next-generation Pantheris across a spectrum of lesions and clinical situations have remained consistently positive and in-line with the early outcomes reported in late June and on the Company's earnings conference call in August 2018.

Dr. Glen Schwartzberg, a vascular surgeon at Baton Rouge General and an experienced user of next-generation Pantheris, commented, "The new design represents a significant step forward in the applicability of this technology into more complex clinical situations, allowing me to use Pantheris as a front-line therapy in many cases. Existing data and my own personal experience have shown the link between vascular injury and the initiation of the inflammatory cascade that contributes to restenosis, or re-narrowing of an artery after an intervention. I now have a tool in Pantheris that optimizes my ability to specifically target diseased segments of the artery while reliably minimizing the collateral trauma that contributes to the recurrence of symptoms, which I believe will lead to the best outcomes for my patients," Dr. Schwartzberg continued.
"We are thrilled with the positive feedback we have received from physicians related to the performance and reliability of the next-generation Pantheris device, and most of all the clinical outcomes they have been able to achieve," said Jeff Soinski, Avinger's President and CEO. "Based on this early success, our salesforce is focused on supporting and expanding utilization in existing Lumivascular accounts and building a pipeline of high-potential new accounts for future expansion."

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