ST. LOUIS, Feb. 27 /PRNewswire-FirstCall/ -- Stereotaxis, Inc. (Nasdaq:
STXS) announced today that the U.S. Food and Drug Administration approved for
marketing the NAVISTAR(R) RMT THERMOCOOL(R) Catheter, which is manufactured by
Biosense Webster, Inc, a Johnson & Johnson company. The NAVISTAR(R) RMT
THERMOCOOL(R) Catheter is used with Stereotaxis' NIOBE(R) Remote Magnetic
Navigation System for mapping and radiofrequency (RF) ablation to treat
irregular heartbeats, or cardiac arrhythmias. Stereotaxis expects that
shipments of the catheter to customers will begin within the next few weeks.
"The magnetic irrigated catheter's approval is the tipping point for
Stereotaxis technology," said Mike Kaminski, Stereotaxis President and CEO.
"Together with the Remote Magnetic Navigation System and our recently
introduced software platform, Navigant 3.0 with QuikCAS(TM), the magnetic
irrigated catheter represents a quantum leap forward for remote ablation
procedures and has demonstrated the potential to establish a new standard of
care for treating cardiac arrhythmias in all chambers of the heart.
"This important milestone will provide our customers an expansion of
system capabilities through the availability of a broad set of magnetic
devices which address the many needs of patients in all chambers of the
heart," added Mr. Kaminski. "We are confident that this product introduction
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 and elsewhere.
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.
-0- 02/27/2009
/CONTACT: Jim Stolze, Chief Financial Officer of Stereotaxis, Inc.,
+1-314-678-6105, or Investors, Doug Sherk or Jenifer Kirtland, both for
Stereotaxis, Inc., +1-415-896-6820; or Media, Steve DiMattia of EVC Group,
Inc, +1-646-201-5445, for Stereotaxis, Inc./
/Web Site: http://www.stereotaxis.com /
(STXS)
CO: Stereotaxis, Inc.; Biosense Webster, Inc, a Johnson & Johnson company
ST: Missouri
IN: HEA MEQ MTC
SU: FDA
PR
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8219 02/27/200913:28 ESThttp://www.prnewswire.com