Stereotaxis, Inc. announced today that it has received regulatory clearance from the U.S. Food and Drug Administration for its magnetically tipped, PowerAssert(TM) radiofrequency (RF) guidewire to cross chronic total occlusions in the peripheral vasculature.

Occluded or blocked arteries occur in patients with advanced peripheral arterial disease (PAD), and if left untreated can result in ulcerations and gangrene as well as significantly increased risk of limb loss and death. Eight to twelve million people have PAD, according to the American Heart Association. Stereotaxis' magnetically steerable RF guidewire is designed to ablate through chronic total occlusions (CTOs) in peripheral arteries. Its Niobe Magnetic Navigation System directs the guidewire's distal tip very precisely, allowing for accurate and efficient navigation through difficult to treat regions of the peripheral vasculature and CTOs.

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias.