Avinger (AVGR) Misses Q4 EPS by 3c; Receives FDA 510(k) Clearance for Enhanced Pantheris System

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Go back to Avinger (AVGR) Misses Q4 EPS by 3c; Receives FDA 510(k) Clearance for Enhanced Pantheris System

Avinger, Inc. Announces Fourth Quarter and Full Year 2015 Results

March 1, 2016 4:05 PM EST

 Pantheris Commercial Launch Underway

REDWOOD CITY, Calif., March 01, 2016 (GLOBE NEWSWIRE) -- Avinger, Inc. (NASDAQ: AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today reported results for the fourth quarter and full year ended December 31, 2015.

Recent Highlights

Commenced commercialization of an enhanced version of the Pantheris image-guided atherectomy system following receipt of a 510(k) clearance from the United States Food and Drug Administration (FDA) on March 1, 2016.Added 13 new lumivascular accounts during the fourth... More

Avinger Announces FDA Clearance and U.S. Launch of Breakthrough Treatment for Patients With Peripheral Artery Disease

March 1, 2016 4:03 PM EST

REDWOOD CITY, Calif., March 01, 2016 (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 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.

I am excited and eager to commercially... More