Avinger's Pantheris SV Receives CE Mark Approval
October 18, 2018—Avinger, Inc. announced CE Mark approval of Pantheris SV (small vessel), a product line extension of the Lumivascular atherectomy system. The approval allows the device to be distributed in the European Union and other countries that recognize the CE Mark. Pantheris SV is not available commercially in the United States. In August, Avinger announced the submission of an application to the FDA for 510(k) clearance of the Pantheris SV.
Avinger's Lumivascular technology allows physicians to see from inside the artery during an atherectomy procedure by using an optical CT (OCT) imaging that is displayed on the company's Lightbox console, allowing more accurate navigation of devices to treat peripheral artery disease lesions.
According to the company, Pantheris SV is designed with a lower profile and longer length to expand the addressable market for Pantheris, allowing physicians to treat lesions in smaller diameter vessels (2–4 mm) and more distal regions of the vasculature.
Pantheris SV incorporates key improvements from the next-generation Pantheris, which was launched in the United States in June 2018. These improvements include a stiffer shaft for increased pushability, a refined OCT imaging system, and an enhanced cutter design, stated Avinger.