Avinger Receives 510(k) Clearance for Design Modifications to Pantheris Atherectomy Device

Avinger Inc., a developer of treatments for peripheral artery disease (PAD), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for modifications to the company’s PantherisÒ 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.
 
“Our continued technology improvements are driven by our commitment to provide physicians with the most advanced tools for treating patients who are suffering the painful and sometimes devastating effects of peripheral artery disease,” said Jeff Soinski, Avinger’s president and CEO. “By receiving 510(k) clearance of this series of incremental improvements incorporated into the current version of Pantheris, we are hopeful that we will provide the opportunity for a more efficient review of our next generation Pantheris atherectomy catheter, which incorporates a number of additional design features and improvements. We anticipate filing a 510(k) submission for this next generation device in the fourth quarter of this year.”
 
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 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. 
 
Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the PantherisÒ family of atherectomy devices. Avinger is based in Redwood City, Calif..