www.fdanews.com/articles/205427-avingers-pantheris-cleared-for-in-stent-restenosis
Avinger’s Pantheris Cleared for In-Stent Restenosis
November 19, 2021
Avinger has received the FDA’s 510(k) clearance for a new clinical indication for its Pantheris image-guided atherectomy system.
Pantheris uses intravascular imaging to enable physicians to visualize stent struts and safely target lesions to restore blood flow to occluded vessels, while avoiding the structure of the previously implanted stent, the company said.
The new FDA clearance allows the company to directly market Pantheris to treat in-stent restenosis in the lower extremity arteries.