Avinger's Enhanced Pantheris Lumivascular Atherectomy System Cleared by FDA

March 1, 2016—Avinger, Inc. announced that the company has received 510(k) clearance from the US Food and Drug Administration (FDA) for an enhanced version of its Pantheris lumivascular atherectomy system, an image-guided atherectomy device for the treatment of peripheral artery disease (PAD). Avinger first received FDA 510(k) clearance for the Pantheris system for the treatment of patients with PAD in October 2015. Avinger will commence United States commercialization of this enhanced version of Pantheris immediately.

According to the company, the enhanced device provides improved ergonomics, physician controls, and manufacturability. The device’s lumivascular technology allows physicians to see from inside the artery during a directional atherectomy procedure by using optical coherence tomography (OCT) to more accurately navigate their devices and treat PAD lesions.

Avinger advised that Pantheris has demonstrated clinical effectiveness and an excellent safety profile. In the recently completed VISION study, 130 patients were treated with Pantheris and were followed for a 6-month period. The study achieved its primary safety and efficacy endpoints and showed a target lesion revascularization rate of just 8%, along with no vessel perforation, clinically significant dissection, or late aneurysm resulting from Pantheris.

Thomas Davis, MD, of St. John Hospital and Medical Center in St. Clair Shores, Michigan, commented in the company’s announcement, “Atherectomy is a proven treatment that relieves pain and restores blood flow, and Pantheris has been eagerly anticipated in the clinical community because it is a leap forward in atherectomy technology compared to what we have had in the past. Now, for the first time, we are able to see exactly where we are removing the plaque and are better able to leave the healthy artery alone. Clinical data suggests that the precision offered with Pantheris will have a lasting positive effect on patient outcomes. In addition, Pantheris visualizes the artery without requiring ionizing radiation. Thus, OCT has the potential to reduce physician and patient x-ray exposure, which is a concern for all clinicians performing multiple procedures.”