FDA Clears Stereotaxis Magnetic Radio Frequency Guidewire for Peripheral Chronic...

FDA Clears Stereotaxis Magnetic Radio Frequency Guidewire for Peripheral
Chronic Total Occlusions
Revolutionary RF Guidewire Adds Large New Market Opportunity to Stereotaxis'
Niobe(R) Platform

ST. LOUIS, Aug. 27 /PRNewswire-FirstCall/ -- Stereotaxis, Inc.
(Nasdaq: STXS), announced today that it has received regulatory clearance from
the U.S. Food and Drug Administration for its magnetically tipped,
PowerAssert(TM) radiofrequency (RF) guidewire to cross chronic total
occlusions in the peripheral vasculature.
Occluded or blocked arteries occur in patients with advanced peripheral
arterial disease (PAD), and if left untreated can result in ulcerations and
gangrene as well as significantly increased risk of limb loss and death. Eight
to twelve million people have PAD, according to the American Heart
Association. Stereotaxis' magnetically steerable RF guidewire is designed to
ablate through chronic total occlusions (CTOs) in peripheral arteries. Its
Niobe Magnetic Navigation System directs the guidewire's distal tip very
precisely, allowing for accurate and efficient navigation through difficult to
treat regions of the peripheral vasculature and CTOs.
"The safety and accuracy of the Stereotaxis system has been well
documented in electrophysiology procedures, as have its ergonomic advantages
and reduction of fluoro exposure," said John Young, MD, Director,
Cardiovascular Innovation Program, The Ohio State University Medical Center,
Columbus, Ohio. "With a growing diabetic population and increased prevalence
of PAD, I am eager to use the magnetic RF guidewire. This will be the first
CTO crossing device that can enable true intra-lesion steering, and I expect
it to substantially improve the range of options for CTO treatment."
"Traditional, manual guidewires used for CTO crossing have little or no
steering ability and therefore can only be used with great difficulty in
tortuous vasculature, requiring a high level of operator skill and carrying a
risk of vessel perforation," said Bevil J. Hogg, CEO of Stereotaxis. "Just as
the safety, accuracy and efficacy of our Niobe Magnetic Navigation System have
contributed significantly to the treatment of patients with cardiac
arrhythmias in the field of electrophysiology, we believe that our PowerAssert
RF guidewire will improve the prospects for treating patients with peripheral
arterial disease. PowerAssert opens a significant new market opportunity for
Stereotaxis, underscoring the Niobe system's capabilities as a platform for a
broad and growing array of interventional procedures."
Stereotaxis is planning a limited clinical introduction of the guidewire
to begin later this year, with a broader commercial launch to follow.
About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiology
instrument control system for use in a hospital's interventional surgical
suite to enhance the treatment of coronary artery disease and arrhythmias. The
Stereotaxis System is designed to enable physicians to complete more complex
interventional procedures by providing image guided delivery of catheters and
guidewires through the blood vessels and chambers of the heart to treatment
sites. This is achieved using computer-controlled, externally applied magnetic
fields that govern the motion of the working tip of the catheter or guidewire,
resulting in improved navigation, shorter procedure time and reduced x-ray
exposure. The core components of the Stereotaxis system have received
regulatory clearance in the U.S., Europe, Canada, China and Australia.
Safe Harbor
This press release includes statements that may constitute
"forward-looking" statements, usually containing the words "believe,"
"estimate," "project," "expect" or similar expressions. Forward-looking
statements inherently involve risks and uncertainties that could cause actual
results to differ materially from the forward-looking statements. Factors that
would cause or contribute to such differences include, but are not limited to,
continued acceptance for the Company's products in the marketplace,
competitive factors, the actual timing of regulatory approvals with respect to
the magnetic irrigated catheter and otherwise, the timing of the
re-introduction of the magnetic irrigated catheter in Europe and in the U.S.,
changes in government reimbursement procedures, dependence upon third-party
vendors, and other risks discussed in the Company's periodic and other filings
with the Securities and Exchange Commission. By making these forward-looking
statements, the Company undertakes no obligation to update these statements
for revisions or changes after the date of this release. There can be no
assurance that the Company will recognize revenue related to its purchase
orders and other commitments in any particular period or at all because some
of these purchase orders and other commitments are subject to contingencies
that are outside of the Company's control. In addition, these orders and
commitments may be revised, modified or canceled, either by their express
terms, as a result of negotiations, or by project changes or delays.
SOURCE Stereotaxis, Inc.

Jim Stolze, Chief Financial Officer of Stereotaxis, Inc., +1-314-678-6105; or
Investors, Doug Sherk & Jenifer Kirtland, +1-415-896-6820; or Media, Steve
DiMattia, +1-646-201-5445, all of EVC Group, Inc., for Stereotaxis, Inc.