Positive two year data for Pantheris system in peripheral artery disease- Avinger

Avinger has announced positive two-year clinical data from the pivotal VISION study designed to evaluate the safety and effectiveness of Avinger�s Pantheris system for peripheral artery disease (PAD), 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. Data from the study, which demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints, supported FDA 510(k) clearance of the system in 2016.

Interim results from 55 patients who completed 24-month follow-up include: Kaplan Meier survival probability measured 86% freedom from target lesion revascularization (TLR) at 12 months and 82% freedom from TLR at 24 months. There were zero (0%) amputations through 24 months and statistically significant improvements in ankle brachial index (ABI) and Rutherford classification at 30 days maintained through 24 months. 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) receiving adjunctive drug coated balloon (DCB) therapy and only 5% (n=10/198) receiving adjunctive stent therapy.