Stereotaxis RF guidewire cleared for peripheral artery disease
This article was originally published in The Gray Sheet
Executive Summary
Stereotaxis' magnetically-tipped, steerable PowerAssert radiofrequency guidewire for crossing chronic total occlusions in the peripheral vasculature will begin a "limited" debut "later this year" to treat peripheral artery disease following FDA market go-ahead, announced Aug. 27. A broader commercial launch will follow, according to the company. The American Heart Association estimates 8 million-12 million people have PAD, the firm states. Clearance provides a "significant new market opportunity" for the firm's Niobe magnetic navigation system, currently used for cardiac electrophysiology procedures, the company notes (1"The Gray Sheet" Aug. 11, 2008, p. 18)