Stereotaxis, Inc. (Nasdaq:
STXS) today announced 510(k) FDA clearance of the Niobe(R) magnetic
navigation system for use in neurovascular and peripheral applications with
the Company's family of Cronus(R) magnetically enabled .014" vascular
guidewires. Stereotaxis had previously received FDA clearance to use the
Niobe System and Cronus guidewire family in coronary vasculature procedures
only.
The Cronus guidewire family will now integrate with the Niobe magnetic
navigation system to provide precise magnetic guidewire navigation in
coronary, neurovascular and peripheral anatomy.
"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."
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.
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 of 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.
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