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|Avinger Announces 24-Month Outcomes from the Pivotal VISION Study of Lumivascular Technology for Peripheral Artery Disease|
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 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 U.S. Food and Drug Administration (FDA) 510(k) clearance of the system in 2016.
Interim results from 55 patients who completed 24-month follow-up were presented by
Key highlights of the presentation include:
“These interim 24-month results demonstrate a stable, consistent, and high-functioning patient population through two years – impressive results for a study of mostly standalone, drug-free atherectomy cases,” said Dr. Cawich. “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.”
European Case Series Demonstrates Consistent Long-Term Outcomes
The study represented the first cohort of Pantheris outcomes patency data (PSVR<2.4), with a rate of 89% at six months and 86% at 12 months. OCT guided atherectomy demonstrated 84% standalone luminal gain and OCT-guided CTO crossing achieved 95% (n=20/21) standalone true lumen crossing. At six months, freedom from TLR of 94.3% closely matched VISION 6-month results of 94%; freedom from TLR at 12 months of 88% also approximates VISION 12-month results of 86%. In addition, the study demonstrated a statistically significant improvement in ABI from baseline to both six and 12 months.
“As a new user, I am very encouraged by our positive long-term results,” said Dr. Brodmann. “Lumivascular treatment demonstrated tremendous efficacy and safety, consistent with the larger pivotal VISION study.”
Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during a directional atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, which is displayed on the Lightbox console. In the past, physicians have had to rely solely on X-ray as well as tactile feedback to guide their tools while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
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