Complete 24-Month Data Presented From the Pivotal VISION Study of Avinger's Lumivascular Technology

May 31, 2017—Avinger, Inc. announced positive 2-year clinical data from the pivotal VISION study of the company’s Lumivascular technology for use in the treatment of peripheral artery disease (PAD). Patrick Muck, MD, presented the data at the New Cardiovascular Horizons (NCVH) conference in New Orleans, Louisiana.

The VISION study was designed to evaluate the safety and effectiveness of Avinger’s Pantheris system to perform directional atherectomy while, for the first time, allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. The VISION data supported US Food and Drug Administration 510(k) clearance of the system, which the company announced in March 2016.

According to Avinger the 24-month follow-up results from 89 patients in the VISION study demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints. This includes an additional 34 patients beyond the interim data set presented by Ian M. Cawich, MD, in January at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany.

The company advised that the data presented at NCVH remain subject to adjustment based on final statistical analysis and review by the study’s clinical events committee. The key findings from VISION included:

• Kaplan Meier survival probability measured 82% freedom from target lesion revascularization (TLR) at 12 months by patient (84% by lesion) and 74% freedom from TLR at 24 months by patient (76% by lesion).
• The VISION 24-month Kaplan Meier freedom from target lesion vascularization at 24 months remained stable between 18 and 24 months.
• Statistically significant improvements in ankle-brachial index and Rutherford classification at 30 days were maintained through 24 months.
• A majority of lesions were treated using standalone optical coherence tomography-guided atherectomy with the Pantheris catheter, with only 9.6% (n = 19/198) receiving adjunctive drug-coated balloon therapy and only 5% (n = 10/198) receiving adjunctive stent therapy.

In the company's announcement, Dr. Muck commented, “The complete VISION 24-month data demonstrate positive longer-term sustained results for patients treated with Pantheris, and importantly, these patients have largely avoided the need for a repeat procedure in a 2-year timeframe. Considering that the outcomes were generated at the hands of brand new users with a first-generation clinical trial device, such positive results represent an important step forward for Pantheris in the clinical setting.” Dr. Muck is Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio.