November 20, 2017 — Avinger Inc. announced in October that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for modifications to its Pantheris Lumivascular atherectomy system. The 510(k) submission covered a series of non-significant design changes already incorporated into commercial products and previously documented as letters to file. The modifications were designed to enhance cutting efficiency, increase product reliability and improve overall ease of use of the Pantheris system.
Avinger President and CEO Jeff Soinski said the company hopes the recent clearance will make for a more efficient review of the next generation of Pantheris, for which Avinger anticipates filing a 510(k) submission in the fourth quarter of 2017.
Atherectomy is a minimally invasive treatment for peripheral artery disease (PAD) in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians to see from inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography (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, 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.
For more information: www.avinger.com
February 15, 2023 
