Avinger Secures FDA 510(k) Clearance for Lightbox L250 Imagine Console

The FDA awarded 510(k) clearance to Avinger’s Lightbox L250 imaging console to provide measurements of vessels before, during, and after atherectomy procedures for the treatment of peripheral artery disease.

The device calculates the area and diameters of vessels in real time to facilitate the placement of adjunctive therapies. It works inside the vessel to determine the levels of stenosis and luminal gain throughout and following minimally invasive endovascular surgeries.