Highmark Health's VITAL Program To Evaluate Avinger's Novel Treatment For Peripheral Artery Disease

Innovative Program Studies Full Impact of New Health Technologies

Pittsburgh, PA and Redwood City, CA (GLOBE NEWSWIRE) - Highmark Health, Allegheny Health Network (AHN) and Avinger, Inc. (NASDAQ:AVGR) announced a collaboration today to evaluate Pantheris™, Avinger’s novel image-guided atherectomy device for the treatment of peripheral artery disease (PAD). The partnership is part of Highmark Health’s VITAL (Verification of Innovation by Testing, Analysis and Learning) Innovation Program.

Pantheris, which recently received 510(k) clearance from the United States Food & Drug Administration (FDA), represents an important leap forward in atherectomy, a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology utilized in the Pantheris system 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 (OCT).

The VITAL program gives technology developers the opportunity to prove the benefits of their new innovations to patients, providers and payers. Through the VITAL program, a combined insurer and provider-based health system will be able to assess, for the first time, the full impact of new technologies by holistically evaluating patient care.

Lumivascular therapies were given unanimous approval by the VITAL committee. The study will evaluate PAD patients treated using both Ocelot™, a lumivascular catheter for treating total arterial blockages, and Pantheris. Acute and long-term outcomes will be compared to a historic cohort of both endovascular and surgical therapies. Follow-up includes claims data analysis to best understand how the patient and all related co-morbidities evolve during the post-treatment period. Since PAD often presents with several other co-morbidities, including hypertension, diabetes, coronary heart disease and heart failure, appropriate therapeutic intervention and renewed mobility of a patient previously limited by PAD may have a large impact on vascular, renal and cardiac outcomes.

“PAD is not an isolated problem. It is part of a disease spectrum that often involves diabetes, high blood pressure, cardiac abnormalities and renal insufficiencies. Accordingly, optimal PAD therapy should aim to understand, treat and improve both local and systemic disease effects,” said Avinger’s Chief Medical Officer Arjun Desai, MD. “By linking delivered care with claims data in a collaborative environment, VITAL is changing the conversation about episodic care and redefining what quality means.”

“VITAL’s mission is to support bringing safe, innovative technologies to members and patients that increase quality of care and lead to better patient outcomes without undue financial burden,” said David Holmberg, President and CEO, Highmark Health. “As one of the largest integrated health care delivery and financing systems in the nation, we embrace our responsibility to accelerate the pace with which novel technologies and services are made available to the public.”

“Using this technology, we now have the ability to clearly see our way through the artery,” said Satish C. Muluk, MD, Director of the Division of Vascular Surgery and Vice Chair of the Department of Thoracic and Cardiovascular Surgery at Allegheny Health Network in Pittsburgh. “This means there is less risk of damaging the artery walls, which can lead to an aggressive healing-and-scarring process that increases the risk of restenosis, or a re-narrowing of the artery after treatment.”

About Highmark Health
Highmark Health, a Pittsburgh, PA based enterprise that employs more than 35,000 people nationwide and serves 40 million Americans in all 50 states, is the third largest integrated health care delivery and financing network in the nation. Highmark Inc. and its subsidiaries and affiliates provide health insurance to 5.3 million members in Pennsylvania, West Virginia and Delaware as well as dental insurance, vision care and related health products through a national network of diversified businesses that include United Concordia Companies, HM Insurance Group, Davis Vision and Visionworks. To learn more, please visit www.highmarkhealth.org or www.vitalinnovationprogram.org or contact Highmark Health at 412-544-0968.

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.

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