Avinger's Pantheris Image-Guided Atherectomy System Cleared by FDA

October 15, 2015—Avinger, Inc. announced that the Pantheris image-guided atherectomy system for the treatment of patients with peripheral arterial disease (PAD) has received 510(k) clearance from the US Food and Drug Administration (FDA) to commence commercialization in the United States. The Pantheris system combines directional atherectomy with real-time, intravascular visualization and is designed to allow interventionists to precisely remove plaque from blocked arteries while avoiding disruption of normal arterial wall structures.

Pantheris received European CE Mark during the second quarter of 2015. The company expects to conduct a broad-scale commercial launch of an enhanced version of Pantheris in the United States within the first quarter of 2016, after receiving the appropriate regulatory approvals.

In the VISION investigational device exemption trial, Pantheris exceeded the study’s safety and efficacy endpoints. Six-month results from an interim analysis of 93 patients out of the 130 patients treated per protocol in the study were presented this week at TCT 2015, the Transcatheter Cardiovascular Therapeutics scientific symposium held October 11–15 in San Francisco, California. Data from this interim cohort was the basis for the 510(k) application Avinger submitted to the FDA on August 12.