Avinger Inc Announces CE Mark Clearance of Next Generation Pantheris Lumivascular Atherectomy System; Shares Soar 10%


It’s a big day for Avinger Inc (NASDAQ:AVGR). The medical device company announced  that it has received CE mark clearance for its next generation Pantheris Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of PAD. The novel design features of the next generation of Pantheris 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.

Avinger shares reacted to the news, soaring nearly 10% to $0.234 in pre-market trading Wednesday. However, 2017 was a rough year for Avinger investors, with shares crashing nearly over 90%.

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Avinger CEO Jeff Soinski stated, “CE Marking approval to market and sell our next generation of Pantheris in Europe and other CE Mark countries represents an important milestone which should benefit both patients and physician users of our technology […] This next generation device incorporates the feedback we have received from our physician partners over nearly two years and should deliver the next level of quality, efficiency, and ease of use to the Pantheris atherectomy system. We are excited to initiate our first clinical experiences with the devices in Europe in the near future.”

Avinger 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.

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