Peripheral Occlusion Tool Approved
The new PowerAssert radiofrequency (RF) guidewire from Stereotaxis, Incorporated was approved by the Food and Drug Administration. The tool is indicated to cross chronic total occlusions in the peripheral vasculature. The company plans a limited launch later this year, followed by a more extensive commercial launch.
The PowerAssert has a magnetically steerable RF guidewire that is intended to ablate through chronic total occlusions (CTOs) in peripheral arteries. The incorporated Niobe Magnetic Navigation System helps direct the distal tip of the guidewire. This support both efficiency and accuracy during navigation, particularly through difficult to treat regions.
The system is particularly intended to treat people suffering from peripheral arterial disease (PAD). Patients who do not receive treatment for this condition can develop gangrene and ulcerations, which may result in limb loss or even death. Approximately ten million people in the U.S. have PAD, according to the American Heart Association.
The company already has a Stereotaxis device on the market indicated for use during electrophysiology procedures. One advantage is a reduction in the amount of fluoro exposure.
Stereotaxis develops tools for advanced cardiology procedures, focusing on the treatment of arrhythmias and coronary artery disease.
August 28, 2008 Related topics: Product Approval & Certification, Cardiology