Stereotaxis nets FDA guidewire clearance to treat CTO in peripheral arteries

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

Stereotaxis has received regulatory clearance from the FDA for its magnetically tipped, PowerAssert radiofrequency (RF) guidewire to cross chronic total occlusions (CTOs) in the peripheral vasculature.

The St. Louis-based Stereotaxis said its magnetically steerable RF guidewire is designed to ablate through CTOs in peripheral arteries. The company said its Niobe magnetic navigation system directs the guidewire’s distal tip very precisely, allowing for accurate and efficient navigation through regions of the peripheral vasculature and CTOs.

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