Avinger Announces Early 510(k) Filing for Pantheris

August 12, 2015—Avinger, Inc. announced that it is filing a submission with the US Food and Drug Administration (FDA) for 510(k) clearance to market its Pantheris image-guided atherectomy device for the treatment of patients with peripheral artery disease.

According to the company, the early submission is supported by the favorable data from the VISION trial. Previously reported 30-day data surpassed the primary VISION efficacy endpoint, and data collection continues for the trial’s 6-month primary safety endpoint. Based on the 6-month data collected to date, and in collaboration with the FDA, Avinger has been allowed to submit the 510(k) application earlier than anticipated. With this early filing, the company hopes to achieve 510(k) marketing clearance for Pantheris by the end of 2015, which would be followed by a United States launch of the device in early 2016, advised Avinger.

The company noted that the FDA has 90 days in which to clear the class II medical device for commercial distribution or to seek additional information. Avinger anticipates that the follow-up on all remaining VISION patients will be completed and provided to the FDA before the end of the 90-day review cycle. Additionally, the company expects to present full results from the VISION trial at a major clinical conference in the fourth quarter of this year.