The FDA has given Stereotaxis a green light to market the company’s magnetically steered PowerAssert RF guidewire for peripheral chronic total occlusions. We have covered Stereotaxis and its NIOBE II remote magnetic system on many occasions before, as our flashbacks at the end of this post testify. We have spoken with a rep for the company who tells us that now, in addition to the previous efforts of Stereotaxis to concentrate on intracardiac procedures, the company will pursue new indications to implement its external magnetic navigation system for peripheral vascular problems.
From a press release by Stereotaxis:
“The major differentiation is that we can steer, in vivo, the wire in the center of the lumen,” said Rick Green of Stereotaxis. “As you know there are a few other companies that use laser or debulking to make path. Stereotaxis crosses the lesion with RF, but with does so with precision and accuracy because of our ability to control the distal tip of the device. No other company controls the tip of the device, which we do through computer control guiding the magnetic technology.”
“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,” said 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.