ST. LOUIS, March 6 /PRNewswire-FirstCall/ -- Stereotaxis, Inc. (Nasdaq:
STXS) announced today that clinicians at two centers in the United States have
performed successful cardiac ablation procedures with the NAVISTAR(R) RMT
THERMOCOOL(R) catheter since the announcement of its approval by the U.S. Food
and Drug Administration on February 26.
In the first procedure with the magnetic irrigated catheter, Dr. Andrea
Natale, Executive Medical Director of the Texas Cardiac Arrhythmia Institute
at St. David's Medical Center in Austin, Texas, successfully treated a 65-year
old male with persistent left-sided abnormal heart rhythm.
"This was a very complicated case," said Dr. Natale. "The procedure was
flawless, and the patient is doing extremely well. We are very pleased with
the performance of the magnetic irrigated catheter. Now that it is available,
we expect to use the Remote Magnetic Navigation System routinely to treat
complex arrhythmias. The power of the magnetic irrigated catheter together
with the precision of the Stereotaxis System represents a significant
improvement in the management of complex arrhythmias."
In a separate case, Dr. David Tschopp, electrophysiologist at The Heart
Hospital of Austin, treated a 72-year old male patient with atrial flutter.
"The performance of the magnetic irrigated catheter was exceptional," said
Dr. Tschopp. "We were able to deliver the necessary therapy and the patient
is doing extremely well. I believe that the combination of remote magnetic
navigation with the irrigated catheter will have the greatest, most immediate
impact on treating complex left sided ablations. It is exciting for this tool
to be available to the millions of people who have this disease."
Prior to FDA approval, Dr. Peter Weiss, MD MSc at Intermountain Medical
Center in Salt Lake City, received a compassionate use exemption to treat a
patient suffering from incessant premature ventricular contractions (PVCs)
that accounted for over 30% of his heart beats each day. After treatment with
the magnetic irrigated catheter, the patient's PVCs were reduced to less than
5% of his total heart beats. The patient had failed medications and two
previous attempts at catheter ablation.
"The details of our case at Intermountain demonstrate the full power of an
irrigated catheter combined with the precision of magnetic navigation," said
Dr. Weiss. "We were able to maneuver the catheter into very
difficult-to-reach anatomy, achieve excellent tissue-catheter contact, and
successfully treat this complicated patient where other treatments had failed.
This has been an extremely gratifying case and we look forward to broader and
more consistent application of the magnetic irrigated catheter for complex
cases at our Center going forward."
"Everyone at Stereotaxis has been preparing for the introduction of the
magnetic irrigated catheter in the U.S.," said Mike Kaminski, Stereotaxis
President and CEO. "With these first cases we have begun with our partner a
phased rollout to our installed base of Niobe systems and we are working very
diligently to be certain each center has the training and resources it needs
to deploy the catheter with success. We're looking forward to seeing a
broader presentation of clinical experiences at the Heart Rhythm Society's
annual meeting in May."
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- 03/06/2009
/CONTACT: Jim Stolze, Chief Financial Officer of Stereotaxis, Inc.,
+1-314-678-6105; or Investors, Doug Sherk, or Jenifer Kirtland,
+1-415-896-6820, for Stereotaxis, Inc.; 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.; Texas Cardiac Arrhythmia Institute at St. David's
Medical Center; The Heart Hospital of Austin; Intermountain Medical
Center; Heart Rhythm Society
ST: Missouri, Texas, Utah
IN: HEA MEQ MTC
SU: PDT
PR
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1543 03/06/200906:00 ESThttp://www.prnewswire.com