Avinger Successfully Completes VISION IDE Trial for Pantheris(TM)

REDWOOD CITY, Calif., Avinger, Inc., a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced that its Pantheris™ system has achieved all safety and efficacy endpoints in six-month follow-up data for its VISION IDE clinical trial. VISION was designed to evaluate the safety and effectiveness of Pantheris to perform directional atherectomy while for the first time ever allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.

VISION results from the 130 patients treated per protocol in the study were presented today at the Vascular Interventional Advances (VIVA) 2015 annual meeting by Arne Schwindt, M.D. of St. Franziskus Hospital in Muenster, Germany, one of the lead principal investigators.

Final VISION trial results demonstrated:

• Primary efficacy endpoint of residual stenosis less than or equal to 50% following Pantheris treatment was achieved in 96.3% (158/164) of lesions, significantly outperforming the pre-defined study goal of 87%;
• Target lesion revascularization (TLR) rate of 8.0% and overall major adverse event (MAE) rate of 17.6% through six-month follow-up, measuring below the pre-defined study limit for MAEs of 43.2%;
• Zero clinically significant dissections, perforations, or late aneurysms related to Pantheris;
• Statistically significant improvement across all patients in both blood flow measurement (Ankle Brachial Index) and symptom-based outcomes (Rutherford Classification);
• Stent placement in only 4% of lesions following treatment with Pantheris;
• Six-month TLR of 6.5% in chronic total occlusion (CTO) subgroup (n=31) with only one instance of adjunctive stent placement; and
• Only 1% adventitia in tissue removed, on average, across all lesions treated.

Commenting on the results of the VISION trial, Dr. Schwindt said, "The positive final data supports the interim results achieved in the first 93 patients, and further highlights the benefit Pantheris offers in treating patients with PAD. Patients experienced no dissections, no perforations, and no late aneurysms related to Pantheris treatment. Moreover, histology confirms the precision of Optical Coherence Tomography (OCT) guidance to aid in the removal of plaque from diseased lower extremity arteries."

The average percent area of adventitia, an indicator of arterial wall disruption, in the atherectomy tissue samples collected was just 1.0% across all lesions treated and analyzed for histology. This histologic analysis highlights the tremendous precision that real-time OCT guidance enables during directional atherectomy, and confirms that real-time imaging provides the feedback necessary for physicians to treat PAD without damaging normal arterial structures such as adventitia.

"Through all aspects of the VISION trial, starting with design, then enrollment, then execution and follow-up, I personally could not have predicted a better outcome. For sure, the results reflect what happens when truly unique devices are investigated by serious investigators working in a collaborative effort with the FDA," said John B. Simpson, Ph.D., M.D., Founder and Executive Chairman of Avinger. "Never before have I been involved in a trial with such consistently positive outcomes. I am confident that we have opened the door on the development of technology that will significantly improve the treatment of peripheral arterial disease."

On October 14, 2015, Avinger received FDA clearance of Pantheris based on an interim analysis of 93 patients. The final data analysis of all patients treated per protocol (n=130) has been filed with the FDA to supplement the 510(k) clearance.

Source: Avinger, Inc.