News | August 26, 2008

FDA Clears Stereotaxis’ PowerAssert Guidewire to Navigate Peripheral CTOs

August 27, 2008 - Stereotaxis Inc. announced yesterday the FDA clearance of its magnetically tipped PowerAssert radiofrequency (RF) guidewire to cross chronic total occlusions (CTOs) 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 CTOs in peripheral arteries. Its Niobe Magnetic Navigation System reportedly directs the guidewire's distal tip in a very precise manner, 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," said John Young, M.D., director, Cardiovascular Innovation Program, The Ohio State University Medical Center, Columbus. "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."
Stereotaxis is planning a limited clinical introduction of the guidewire to begin later this year, with a broader commercial launch to follow.
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