Company Update (NASDAQ:AVGR): Avinger Inc Issues 510(k) Filing of First-Ever Image-Guided Atherectomy Device to Treat Peripheral Artery Disease


Avinger Inc (NASDAQ:AVGR) trumpets the news today of the healthcare player’s submission to the FDA of a new 510(k) application for its next generation of Pantheris. The company has high hopes for its first-ever image-guided atherectomy device, designed to treat peripheral artery disease (PAD), with a commercial game plan for Pantheris Lumivascular to be available to the public by the close of the new year’s first quarter.

The novel design features covered in the filing include a simplified single balloon system for both apposition of the device and occlusion of blood flow, a stiffer shaft for increased pushability, a more robust nose cone with the option for more tissue storage capacity, and an enhanced cutter design.

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“We have received invaluable feedback from physician users that our engineering team has incorporated into the design of our next generation of Pantheris,” said Jeff Soinski, Avinger’s President and CEO. “The upgraded features captured in this submission should bring the next level of quality, efficiency and ease of use to the product. We are hopeful that this filing will lead to FDA clearance of the next generation device in the U.S. by early next year, which would allow the product to be commercially available by the end of the first quarter.”

Patrick Muck, M.D., Chief of Vascular Surgery at Good Samaritan Hospital in Cincinnati, Ohio, commented, “The Pantheris Lumivascular atherectomy system, through its combination of onboard image-guidance and directional plaque removal, has changed my approach to treating peripheral artery disease. As a regular user of the current version of Pantheris, I believe the proposed enhancements represent an important step forward, and I am excited to incorporate the next generation Pantheris into the mainstream of my PAD treatment algorithm.”

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 an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger’s proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions 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.

Shares of Avinger Inc. closed yesterday at $0.2187, up $0.01 or 3.16%. AVGR has a 1-year high of $4.55 and a 1-year low of $0.21. The stock’s 50-day moving average is $0.25 and its 200-day moving average is $0.34.

Avinger, Inc. is a commercial-stage medical device company that designs, manufactures and sells image-guided, catheter-based systems that are used by physicians to treat patients with peripheral artery disease, or PAD. Its products include Pantheris, Lightbox, Ocelot, Ocelot MVRX, Ocelot PIXL, Pantheris, Wildcat, Juicebox and Kittycat 2. The company offers its products to interventional cardiologists, vascular surgeons, and interventional radiologists.