Avinger's Pantheris SV Atherectomy System Receives FDA Clearance
April 10, 2019—Avinger, Inc. announced that the company has received FDA 510(k) clearance for its Pantheris SV image-guided atherectomy system, which is indicated for the diagnosis and treatment of peripheral artery disease in small vessels (2–4 mm in diameter). Pantheris SV is an extension of Avinger’s Lumivascular platform.
The company will initiate a limited launch of Pantheris SV at several sites in the United States when the commercial product is available. Expanded distribution of Pantheris SV is expected as the company gains additional clinical experience, builds product inventory, and receives purchasing approvals in new Lumivascular sites. Pantheris SV received European CE Mark approval in October 2018.
According to the company, Pantheris SV is designed with a lower profile and longer length than Pantheris. Additionally, the device incorporates key improvements introduced to the platform with the launch of the next-generation Pantheris system in June 2018, including a stiffer shaft for increased pushability, a refined optical coherence tomography (OCT) imaging system, and an enhanced cutter design. Avinger's Lumivascular technology uses an OCT that is displayed on the company's Lightbox console to allow physicians to see from inside the artery during an atherectomy procedure.