Avinger this week announced that it received FDA 510(k) clearance for a new clinical indication for its Pantheris image-guided atherectomy system. The new indication allows the Redwood City, California–based company to market the device for in-stent restenosis (ISR) treatment in the lower extremity arteries. “We are excited to receive FDA … [Read more...] about FDA clears Avinger’s Pantheris for in-stent restenosis

Avinger this week announced it received FDA 510(k) clearance for its Ocelaris image-guided chronic total occlusion crossing system. The device will be marketed under the brand name TigerEye and will provide real-time imaging from inside the vessel during CTO-crossing procedures. “We are excited to receive U.S. pre-marketing clearance for … [Read more...] about FDA clears Avinger image-guided CTO crossing system