Stereotaxis Receives Notice of European Approval of an Additional Magnetic Irrigated Catheter

Fri Oct 30, 2009 6:30am EDT
 
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Stereotaxis Receives Notice of European Approval of an Additional Magnetic
Irrigated Catheter



ST. LOUIS, Oct. 30 /PRNewswire/ -- Stereotaxis received notice that the
Celsius® RMT ThermoCool®  catheter has received CE Mark for distribution in
the European market.  The product is the fifth advanced ablation catheter
resulting from the on-going co-development agreement between Stereotaxis and
Biosense Webster to design and distribute magnetically enabled catheters for
use in the Niobe Magnetic Navigation System (MNS). 

A pre-market approval (PMA) application supplement for the Celsius® RMT
ThermoCool® catheter was submitted to the U.S. Food and Drug Administration in
September.

The Celsius® RMT and NaviStar® RMT families of catheters are the only magnetic
catheters accurately matched to the navigational software of the Niobe(TM) MNS
for optimal performance and highly precise catheter manipulation.

This catheter fills out the family of magnetic irrigated catheters to offer
both localized and non-localized technology. Localized catheters are used for
more complex arrhythmias requiring 3D electro-anatomic mapping for precise
diagnosis, whereas non-localized catheters are typically used for simpler
arrhythmias which can be treated using basic imaging and ECG recordings.

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

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

 

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