Stereotaxis Gains U.S. FDA Clearance

Stereotaxis Inc. has received regulatory clearance from the U.S. Food and Drug Administration for its magnetically-tipped, PowerAssert radio frequency (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 12 million people have PAD, according to the American Heart Association. Stereotaxis' magnetically steerable RF guidewire is designed to ablate through chronic total occlusions (CTO s) 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.

"The safety and accuracy of the Stereotaxis system has been well documented in electrophysiology procedures, as have its ergonomic advantages and reduction of fluoro exposure," says John Young, MD, director, Cardiovascular Innovation Program, The Ohio State University Medical Center, Columbus, OH. "With a growing diabetic population and increased prevalence of PAD, I am eager to use the magnetic RF guidewire. This will be the first CTO crossing device that can enable true intra-lesion steering, and I expect it to substantially improve the range of options for CTO treatment."

"Traditional, manual guidewires used for CTO crossing have little or no steering ability and therefore can only be used with great difficulty in tortuous vasculature, requiring a high level of operator skill and carrying a risk of vessel perforation," says Bevil J. Hogg, CEO of Stereotaxis. "Just as the safety, accuracy and efficacy of our Niobe Magnetic Navigation System have contributed significantly to the treatment of patients with cardiac arrhythmias in the field of electrophysiology, we believe that our PowerAssert RF guidewire will improve the prospects for treating patients with peripheral arterial disease. PowerAssert opens a significant market opportunity for Stereotaxis, underscoring the Niobe system's capabilities as a platform for a broad and growing array of interventional procedures."

Stereotaxis is planning a limited clinical introduction of the guidewire to begin later this year, with a broader commercial launch to follow. stereotaxis.com