Avinger Completes Enrollment for VISION Clinical Trial of Pantheris System

March 12, 2015—Avinger, Inc. announced that it has completed enrollment for its VISION clinical study. This trial is designed to evaluate the safety and efficacy of the Pantheris system, which combines directional atherectomy with real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.

In July 2014, Avinger commenced enrollment of a 133-patient trial in the United States and Europe after the US. Food and Drug Administration granted the company an investigational device exemption for Pantheris. Primary safety and efficacy endpoint analysis results will be used to support a 510(k) application, which is anticipated to be filed in the second half of 2015. Avinger expects to present interim 30-day data in the second quarter and 6-month data in the fourth quarter of 2015, the company stated.

“Participation in the VISION trial has been not only a privilege but an eye-opening experience. Never before have we had this much information available, in real time, about the disease and structures on the inside of the artery,” stated Lead Enroller Barry Tedder, MD, Interventional Cardiologist of St. Bernards Hospital in Jonesboro, Arkansas, in the company’s press release. “I believe that the Pantheris catheter for atherectomy and the lumivascular approach more broadly have the potential to revolutionize the treatment of vascular disease.”