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Stereotaxis wins approval for magnetic radio frequency guidewire

Stereotaxis, a manufacturer and marketer of cardiology instrument control systems, has received regulatory clearance from the FDA for its magnetically tipped, PowerAssert radiofrequency guidewire to cross chronic total occlusions in the peripheral vasculature.

Stereotaxis’s magnetically steerable radiofrequency guidewire is said to be designed to ablate through chronic total occlusions (CTO) 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 is planning a limited clinical introduction of the guidewire to begin later in 2008, with a broader commercial launch to follow.

Bevil Hogg, CEO of Stereotaxis, said: “We believe that our PowerAssert RF guidewire will improve the prospects for treating patients with peripheral arterial disease.

“PowerAssert opens a significant new market opportunity for Stereotaxis, underscoring the Niobe system’s capabilities as a platform for a broad and growing array of interventional procedures.”