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Avinger (AVGR) announces receipt of FDA 510(k) clearance of Pantheris SV device

Press releases may be edited for formatting or style
Avinger, Inc. (Nasdaq: AVGR), a leading developer of image-guided, catheter-based systems for the diagnosis and treatment of patients with Peripheral Artery Disease (PAD), today announced that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Pantheris SV (Small Vessel) image-guided atherectomy system.

Pantheris SV, a product line extension of Avinger’s Lumivascular image-guided atherectomy platform, is expected to expand the available market for Pantheris by up to 50% and allow the Company to address a larger portion of the estimated $500 million atherectomy market. Designed with a lower profile and longer length than Pantheris, Pantheris SV is indicated for the diagnosis and treatment of PAD in small vessels (2 to 4 millimeters in diameter). Pantheris SV incorporates key improvements introduced to the platform with the launch of the next-generation Pantheris system in June 2018, including a stiffer shaft for increased pushability, a refined OCT imaging system, and an enhanced cutter design.

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Pantheris SV received CE Marking in October 2018 and the first patients were treated with the device in Germany in November. The Company intends to initiate a limited launch of Pantheris SV in several sites in the United States when commercial product is available. Distribution of Pantheris SV is expected to be expanded as the Company gains additional clinical experience, builds product inventory, and receives purchasing approvals in new Lumivascular sites.

“We are excited to receive U.S. pre-marketing clearance for Pantheris SV, which we believe could expand our addressable market for atherectomy procedures by as much as 50%,” said Jeff Soinski, Avinger’s President and CEO. “With the clearance of this new device, we are well-positioned to build on the positive momentum we have seen in our Pantheris business since the introduction of the next-generation system in 2018. Following our anticipated limited launch of Pantheris SV, we plan on leveraging our growing commercial infrastructure and installed base of Lumivascular accounts to efficiently scale up the introduction of Pantheris SV and drive growth of our Pantheris product family in the second half of 2019.”

Dr. Jaafer Golzar, Avinger’s Chief Medical Officer and a highly experienced interventionalist treating patients with small vessel disease, commented, “This product line extension represents a significant advancement for patients with PAD, in particular those suffering from the complications of small vessel disease. Treating small vessels presents a number of challenges and physicians have had a limited set of minimally invasive tools that can provide safe and effective outcomes for this high-risk patient population. Pantheris SV uses a combination of directional atherectomy with onboard image-guidance to provide several potential clinical advantages, including an enhanced safety profile, the ability to maximize luminal gain without causing vascular injury, and precise vessel measurement capabilities.”

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.

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