Avinger announced that an image-guided atherectomy system for the diagnosis and treatment of patients with peripheral artery disease received 510(k) clearance from the FDA.
The system (Pantheris SV, Avinger) is an updated version of a previous system (Pantheris, Avinger) that was cleared for marketing by the FDA in July 2018. This newer version has a longer length and lower profile, allowing it to be used in small vessels between 2 mm and 4 mm in diameter, according to a press release from the company. It also includes an enhanced cutter design, stiffer shaft and a refined optical CT imaging system.
This activity is supported by an educational grant from Actelion Pharmaceuticals US, Inc.
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