Avinger (Redwood City, CA) has received FDA clearance for an optical coherence tomography (OCT) system that lets surgeons see inside an artery in real time. Previously, surgeons had to rely on x-ray imaging and tactile feedback to guide catheters through complicated blockages.
The approval followed a global clinical trial during which the Ocelot catheter demonstrated 97% success in crossing chronic total occlusions (CTO) with 98% freedom from major adverse events. Ocelot targets periphery artery disease (PAD), which results when plaque in the arteries blocks blood flow to the legs and feet, and promises to help patients avoid bypass surgeries and amputations.