Healthcare Industry News: magnetic navigation
News Release - June 21, 2007
Stereotaxis Announces 1000 Worldwide Atrial Fibrillation Procedures with Niobe(R) SystemExcellent Initial Experience with High Powered Catheters
ST. LOUIS, June 21 (HSMN NewsFeed) -- Stereotaxis, Inc. (Nasdaq: STXS ) announced today that it has achieved an important milestone of over 1000 Atrial Fibrillation procedures performed worldwide with its proprietary Niobe® magnetic navigation system. Atrial Fibrillation is a complex arrhythmia, typically originating in the left atrium of the heart, affecting millions of patients worldwide.
"The Stereotaxis system has established a very strong record of safety and efficacy in the mapping and ablation of arrhythmias," said Bevil Hogg, CEO of Stereotaxis. "We now expect to greatly expand our left sided procedures following the recent regulatory approval for higher powered catheters in Europe and in the US, and to see a concomitant increase in overall clinical utilization rates."
"We are using the Stereotaxis system daily for the ablation of routine and complex arrhythmia," said Jeffrey Olgin, MD, Chief, Cardiac Electrophysiology, University of California San Francisco. "In particular, the system has made left sided procedures easier, with excellent clinical results. The new 8mm ablation catheter is further improving results by providing excellent contact and higher power delivery. The Niobe® system has the potential to become the new standard of care for complex and left side ablation procedures."
The Stereotaxis partnered irrigated catheter, which has received CE mark approval in Europe, was recently tested by physicians from the Cleveland Clinic. "This magnetic irrigated catheter was able to create excellent linear lesion sets. The results indicate that the magnetic system may provide more consistent catheter contact without excessive pressure. We are already using the Niobe® system as part of our daily clinical practice and look forward to gaining clinical experience with this irrigated catheter," said J. David Burkhardt, MD, FACC of the Cleveland Clinic.
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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