Two-Year Outcomes Presented From VISION Study of Avinger's Lumivascular Technology

January 25, 2017—Avinger, Inc. announced that 2-year clinical data from the pivotal VISION study of the company’s Lumivascular technology were presented at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany.

According to the company, the VISION study was designed to evaluate the safety and effectiveness of Avinger’s Pantheris system to perform directional atherectomy while allowing for the use of real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. Data from the study demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints. These data supported US Food and Drug Administration 510(k) clearance of the system in 2016.

Ian M. Cawich, MD, presented interim results from 55 patients who completed 24-month follow-up that included:

• Kaplan-Meier survival probability measured 86% freedom from target lesion revascularization (TLR) at 12 months and 82% freedom from TLR at 24 months
• Zero amputations through 24 months
• Statistically significant improvements in ankle-brachial index (ABI) and Rutherford classification at 30 days maintained through 24 months

As noted in the company's press release, a majority of lesions were treated using standalone optical coherence tomography (OCT)-guided atherectomy with the Pantheris catheter, with only 9.6% (n = 19/198) undergoing adjunctive drug-coated balloon therapy and only 5% (n = 10/198) undergoing adjunctive stent therapy.

Dr. Cawich commented in the announcement, “These interim 24-month results demonstrate a stable, consistent, and high-functioning patient population through 2 years; impressive results for a study of mostly standalone, drug-free atherectomy cases. The findings are particularly striking considering that all data generation and outcomes were in the setting of a first-generation clinical trial device and brand new users.”

Also at LINC 2017, Marianne Brodmann, MD, presented a prospective case series of 30 patients (35 lesions) with long-term follow-up, including duplex patency and freedom from TLR at 6 and 12 months. The study represented the first cohort of Pantheris outcomes patency data (peak systolic velocity ratio < 2.4), with a rate of 89% at 6 months and 86% at 12 months. OCT-guided atherectomy demonstrated 84% standalone luminal gain and OCT-guided chronic total occlusion crossing achieved 95% (n = 20/21) standalone true lumen crossing.

At 6 months, a freedom from TLR rate of 94.3% closely matched the VISION 6-month results of 94%; 88% freedom from TLR at 12 months also approximates the VISION 12-month results of 86%. In addition, the study demonstrated a statistically significant improvement in ABI from baseline to both 6 and 12 months.

Dr. Brodmann stated in Avinger's press release, “As a new user, I am very encouraged by our positive long-term results. Lumivascular treatment demonstrated tremendous efficacy and safety, consistent with the larger pivotal VISION study.”