FDA clears IntraLuminal's total occlusion guide wire:
This article was originally published in Clinica
Executive Summary
IntraLuminal Therapeutics has received US FDA 510(k) clearance to market the first of several generations of its total occlusion products, the Safe-Steer guide wire system. The product is designed to give the cardiologist real-time feedback as to the proximity of the crossing wire to the arterial wall. This should facilitate safe and successful passage through the total occlusion and placement of therapeutic catheters for recanalisation in native coronary arteries, says the Carlsbad, California firm. The market for products designed to cross and recanalise total occlusions is worth $1 billion, the company adds.