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Avinger Receives 510(k) Clearance for Design Modifications to Enhance Performance of Pantheris Image-Guided Atherectomy Device

AVINGER INC (AVGR)  More Company Research Source: GlobeNewswire
Last avinger inc earnings: 8/8 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.avinger.com
PDF REDWOOD CITY, Calif., Oct. 31, 2017 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for modifications to the company’s Pantheris® Lumivascular atherectomy system. The 510(k) submission covered a series of non-significant design changes already incorporated into commercial products and previously documented as letters to file. The modifications were designed to enhance cutting efficiency, increase product reliability, and improve overall ease of use of the Pantheris system. “Our continued technology improvements are driven by our commitment to provide physicians with the most advanced tools for treating patients who are suffering the painful and sometimes devastating effects of peripheral artery disease,” said Jeff Soinski, Avinger’s president and CEO. “By receiving 510(k) clearance of this [Read more]

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