REDWOOD CITY, Calif. and LEIPZIG, Germany, Jan. 25, 2017 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular™ technology.
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 Ian M. Cawich, M.D., cardiologist at Arkansas Heart Hospital, at the Leipzig Interventional Course (LINC) in Leipzig, Germany.
Key highlights of the presentation include:
- Kaplan Meier survival probability measured 86% freedom from target lesion revascularization (TLR) at 12 months and 82% freedom from TLR at 24 months
- Zero (0%) amputations through 24 months
- 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
“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
In addition, Marianne Brodmann, M.D., of the Medical University of Graz in Austria, presented a prospective case series of 30 patients (35 lesions) with long-term follow up including duplex patency and freedom from TLR at six and 12 months.
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.
About Avinger, Inc.
Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems for the treatment of patients with peripheral artery disease (PAD). PAD is characterized by a build-up of plaque in the arteries that supply blood to the legs and feet. The company’s mission is to dramatically improve the treatment of vascular disease through the introduction of products based on its Lumivascular platform, the only intravascular image-guided system of therapeutic catheters available in this market. Avinger’s current Lumivascular products include the Lightbox imaging console, the Ocelot family of catheters, which are designed to penetrate total arterial blockages, known as chronic total occlusions, or CTOs, and Pantheris, the first-ever image-guided atherectomy device, designed to precisely remove arterial plaque in PAD patients. For more information, please visit www.avinger.com.