Stereotaxis announces FDA approval of magnetic irrigated catheter

Jan 16 2008

Stereotaxis, Inc. has announced that the Company has been advised that the U.S. Food and Drug Administration (FDA) has approved its partnered magnetic irrigated catheter for use in mapping and ablation in the United States.

"The long-awaited FDA approval of our partnered irrigated catheter is a very significant milestone for Stereotaxis," said Bevil J. Hogg, Chief Executive Officer of Stereotaxis. "Since its approval and introduction in Europe, the irrigated catheter has been used to successfully treat complex left-sided arrhythmias at a number of leading hospitals in Europe. Patient outcomes have been excellent. The Stereotaxis Magnetic Navigation System, used in conjunction with the magnetic irrigated catheter and the Company's latest software release has performed extremely well with a high degree of safety. We believe that these results will be duplicated at centers in the U.S., and we are confident that the Stereotaxis Magnetic Navigation System with the irrigated catheter has the potential to establish a new standard of care in the treatment of complex arrhythmias. A broad spectrum of thought leaders will present their initial experience with the magnetic irrigated catheter in European centers during the Boston Atrial Fibrillation Symposium on January 17 and 18, and we eagerly look forward to their presentations.

"There is significant pent-up demand for our solution among both existing and prospective customers," continued Mr. Hogg. "As a result, once the irrigated catheter becomes broadly available in the U.S., we anticipate a return to strong pipeline and order growth for our Magnetic Navigation System and accelerated growth in usage rates and related recurring revenues. We are highly confident that this momentum will be transformative for our company."