FDA Clearance Expanded for Stereotaxis

 

November 7, 2006

Stereotaxis has received FDA 510(k) clearance for its Niobe magnetic navigation system for use in neurovascular and peripheral applications with the company's family of Cronus magnetically enabled .014" vascular guide wires. The Niobe System and Cronus guide wires were previously cleared for coronary vasculature procedures only.

The Cronus guide wire family will now integrate with the Niobe magnetic navigation system to provide precise magnetic guide wire navigation in coronary, neurovascular and peripheral anatomy, according to a company press statement.

"While we have no current plans to immediately move into peripheral and neurovascular clinical applications, this clearance provides us with the flexibility to do so at a time of our choosing," said Bevil Hogg, President and Chief Executive Officer of Stereotaxis, Inc. "We believe this latest clearance is further evidence of the broad applicability of our system to the entire body."