Avinger's Pantheris OCT–Guided Directional Atherectomy System Studied in VISION IDE Trial

November 2, 2015—Results of the VISION investigational device exemption (IDE) trial for the Pantheris optical coherence tomography (OCT)–guided directional atherectomy system (Avinger, Inc.) were presented by Arne Schwindt, MD, during the first Late-Breaking Trials session at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

The results demonstrated that the Pantheris atherectomy system, using real-time OCT guidance for directional atherectomy in peripheral artery disease (PAD), is safe and effective. Additionally, low bailout stenting rates combined with low adventitial injury across all lesions treated produced favorable target lesion revascularization (TLR) rates at 6 months.

VISION was a prospective, single-arm, nonrandomized, global IDE trial. Efficacy and safety endpoints were adjudicated via an independent clinical events committee and angiographic core lab.

The study’s primary cohort included 130 patients (n = 164 lesions), with 125 patients completing 6-month follow-up. The primary efficacy endpoint was achieved with 96.3% of lesions treated to ≤ 50% stenosis after treatment with Pantheris alone. The primary safety endpoint was achieved with 17.6% major adverse events verified through 6 months, including an adjudicated TLR rate of 8%. Bailout stenting measured 4.3% (n = 7 lesions). Histologic analysis of atherectomy tissue specimens after Pantheris treatment demonstrated 1% adventitia by area across all lesions treated, reported Dr. Schwindt.

On October 15, Avinger announced that the Pantheris image-guided atherectomy system received 510(k) clearance from the US Food and Drug Administration.