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FDAnews Device Daily Bulletin

Avinger’s Image-Guided Atherectomy Device Cleared by FDA

April 11, 2019

Avinger received 510(k) clearance for its Pantheris SV product, a small vessel image-guided atherectomy system.

The Pantheris SV is an extension of the devicemaker’s Lumivascular image-guided atherectomy platform that is indicated for diagnosing and treating peripheral artery disease in vessels two to four millimeters in diameter.

The device offers improvements like an improved cutter design, a shaft with improved pushability and a superior optical coherence tomography imager.

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