Stereotaxis first CTO crossing procedure received FDA approval

Stereotaxis, Inc. announced the first crossing of a chronic total occlusion using the RF PowerAssert(TM) magnetic guidewire cleared by the U.S. Food and Drug Administration in 2008, the RF PowerAssert guidewire is the only magnetically enabled device available for crossing peripheral occlusions, including CTOs. Used with the Niobe Magnetic Navigation System, it is an innovative solution that enables precise intra-lesion control of its distal tip.

Stereotaxis, Inc. announced the first crossing of a chronic total occlusion using the RF PowerAssert(TM) magnetic guidewire cleared by the U.S. Food and Drug Administration in 2008, the RF PowerAssert guidewire is the only magnetically enabled device available for crossing peripheral occlusions, including CTOs. Used with the Niobe Magnetic Navigation System, it is an innovative solution that enables precise intra-lesion control of its distal tip.

Dr. Zidar said, This new magnetic guidewire technology provided great control and improved accuracy over traditional, manual guidewires. Once we reached the blockage, the tip of the guidewire burned a tiny passage through the blockage, allowing us then to use existing techniques to open up the blockage further and restore healthy blood flow to the patient's leg. This revolutionary technology will likely reduce procedures times, and therefore reduce the amount of contrast dye and imaging radiation to the patient.

Austin Heart interventional cardiologist Frank Zidar, M.D. used the new device on January 7th, on a patient with severe peripheral artery disease (PAD). The patient had 100% blockage in a main artery in his leg that caused chronic, severe pain due to poor circulation. Dr. Zidar performed this procedure at Heart Hospital of Austin.