Form 8-K Avinger Inc For: Mar 01
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Avinger (AVGR) Misses Q4 EPS by 3c; Receives FDA 510(k) Clearance for Enhanced Pantheris System
March 1, 2016 5:14 PM ESTAvinger (NASDAQ: AVGR) reported Q4 EPS of ($1.07), $0.03 worse than the analyst estimate of ($1.04). Revenue for the quarter came in at $2.9 million versus the consensus estimate of $3.08 million.
Avinger also announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for an enhanced version of its Pantheris lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of PAD. Avinger will commence U.S. commercialization of this enhanced version of Pantheris immediately, which features improved ergonomics, physician controls and manufacturability.
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