Avinger Enrolls First PAD Patient in VISION Global Clinical Trial

Avinger Inc. announced that enrollment has begun in the VISION clinical trial to evaluate the company’s Pantheris catheter for the treatment of peripheral artery disease. VISION is a global investigational device exemption trial approved by the U.S. Food and Drug Administration.

VISION’s co-principal Investigators are William Crowder, M.D., and J. Gray Bennett, M.D., of St. Dominic Hospital in Jackson, Mississippi.

According to Avinger, VISION is a nonrandomized, prospective, global, single-arm clinical trial that is evaluating the safety and effectiveness of the Pantheris catheter to perform directional atherectomy while using intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. As part of the trial, an independent group of physicians will review the angiography results to determine the device’s efficacy and safety. The minimally invasive Pantheris catheter is designed to remove plaque while avoiding the disruption of normal arterial wall structures.

John Pigott, M.D., of Jobst Vascular Institute in Toledo, Ohio, enrolled the first patient in VISION. “For the first time ever, I am able to visualize the inside of the artery and selectively remove plaque without disrupting the healthy portion of the vessel. This has the potential to revolutionize the treatment of vascular disease,” Pigott said in a news release announcing the trial.

Crowder and Bennett added: “We are convinced that Avinger’s Pantheris catheter will be a major step forward for our patients and for the entire medical community, as the increased precision allowed by direct visualization is immediate and significant.”

The Pantheris atherectomy catheter incorporates Avinger’s “lumivascular” technology, which the company is developing for devices to treatment vascular disease. The company said lumivascular procedures use an interventional catheter system that incorporates light-based, radiation-free, intravascular imaging technology within the actual therapeutic device. This is designed to provide live, real-time, video-rate images of the inside of an artery during treatment. 

The company’s first lumivascular device, Ocelot, has been commercially available since it was approved in late 2012 for the treatment of chronic total occlusions in the legs of patients with peripheral artery disease. John B. Simpson, M.D., founded Redwood City, Calif.-based Avinger in 2007.