Healthcare Industry News: magnetic navigation
News Release - February 23, 2006
Stereotaxis Announces Initial U.S. Clinical Usage of Partnered 3-D Localized Ablation Catheter with Company's Niobe(R) SystemSuccessful Ablation Completed at Central Baptist Hospital-Lexington Utilizing a 3-D Localized Ablation Catheter and Niobe magnetic navigation System
ST. LOUIS, Feb. 23 (HSMN NewsFeed) -- Stereotaxis, Inc. (Nasdaq: STXS ) today announced that Central Baptist Hospital-Lexington, KY became the first U.S. center to successfully treat a patient's cardiac arrhythmia using our partnered 3-D Localized Ablation Catheter. This diagnostic and ablation catheter recently received FDA approval for use with the Stereotaxis Niobe® magnetic navigation System. This approval builds on the existing CE mark in Europe and provides Stereotaxis Niobe system users in the U.S. with 3-D localization of the catheter tip, a function that offers physicians precise and efficient control of the catheter tip with constant feedback as to the exact location of the catheter in the anatomy.
This initial procedure treated a complex arrhythmia, and was successfully completed by Gery Tomassoni, M.D., at Central Baptist Hospital, in Lexington, KY. Prior to successfully utilizing the partnered ablation catheter, two conventional (4mm and 8mm tip) ablation catheters failed to adequately treat the arrhythmia due to catheter instability. With the use of the Stereotaxis System, the procedure was successfully completed as a result of the combination of enhanced stability and intra-cardiac visualization.
"The Stereotaxis Niobe System, in combination with the 3-D Localization System, now provides physicians with an unprecedented view of a catheter within a precise map of the cardiac anatomy," said Dr. Tomassoni. "During this complex ablation, we were able to precisely adjust the tip of the catheter and maintain tissue contact critical to success. Having knowledge of where the catheter tip is within the body and consistent magnetic catheter contact is certain to improve patient safety and shorten procedure times."
Physicians in Europe have been able to utilize the Stereotaxis family of partnered catheters with the Stereotaxis System since CE Mark authorization was received in March 2005. Since that time, over 450 patients with a variety of routine and complex arrhythmias, including atrial fibrillation (AF) and supra ventricular tachycardia, have been treated in Europe utilizing the Stereotaxis System.
"We have performed several hundred ablations, including about 130 atrial fibrillation procedures, using Stereotaxis' technology," said Carlo Pappone, M.D., Ph.D., FACC, Director of the Arrhythmology Department at San Raffaelle University Hospital, Milan, Italy. "AF is the world's most common heart rhythm disorder, affecting approximately 6 million people worldwide. I believe Stereotaxis' technology could become the standard of care in treating AF patients."
"The recent FDA approval of a Non-Localized Ablation Catheter, and now a 3-D Localized Ablation Catheter, provides to physicians leading diagnostic, ablation, mapping, and steering technologies that should result in the ability to treat a broad range of patients, including both routine and complex cases," said Bevil Hogg, President and CEO of Stereotaxis. "Therefore, we expect these recent FDA approvals to lead to a steady ramp in the utilization of our system in the U.S."
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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