Avinger receives FDA nod for image-guided device

Intravascular imaging technology developer Avinger has received U.S. Food & Drug Administration (FDA) 510(k) clearance for its Pantheris small vessel (SV) image-guided atherectomy system.

An extension of the firm's Lumivascular image-guided atherectomy platform, Pantheris SV is designed for the diagnosis and treatment of patients with peripheral artery disease in vessels that range from 2 to 4 mm in diameter. The device features a stiffer shaft, an enhanced optical coherence tomography (OCT) system, and an improved cutter design compared with the Pantheris system that was introduced in June 2018, according to the company.

Avinger received the CE Mark in Europe for Pantheris SV in October 2018, and the first patients were treated with the system in Germany in November 2018. The company said it plans a limited launch of Pantheris SV in several sites in the U.S., with broader distribution expected as Avinger gains clinical experience, builds product inventory, and receives purchasing approvals in new Lumivascular sites.

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