Stereotaxis Announces FDA Approval of Its Partnered Magnetic Irrigated Catheter
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Important Milestone for Treatment of Complex Arrhythmias Achieved
ST. LOUIS, Jan. 15 /PRNewswire-FirstCall/ -- Stereotaxis, Inc.
(Nasdaq: STXS) announced today 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."
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 and Canada.
About Forward Looking Statements
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, 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 we will
recognize revenue related to our 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 our 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.
company contact, Jim Stolze, Chief Financial Officer of Stereotaxis, Inc.,
+1-314-678-6105; or investor contact, Doug Sherk or Jenifer Kirtland,
+1-415-896-6820; or media contact, Steve DiMattia of EVC Group, Inc.,
+1-646-201-5445, all for Stereotaxis, Inc.
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