Healthcare Industry News: Biosense Webster
News Release - January 12, 2006
Stereotaxis Announces Initial U.S. Clinical Usages of Cardiac Ablation Catheter With Company's Niobe(R) SystemSignificant Milestone Achieved With Successful Complex Ablations Completed at Three Leading U.S. Electrophysiology Centers Utilizing the Proprietary CELSIUS(R) RMT Diagnostic and Ablation Catheter and Stereotaxis Niobe Magnetic Navigation System
ST. LOUIS, Mo., Jan. 12 (HSMN NewsFeed) -- Stereotaxis, Inc. (Nasdaq: STXS ) today announced the achievement of a significant milestone with three leading electrophysiology sites becoming the first U.S. centers to successfully treat cardiac arrhythmias using the Celsius® RMT Diagnostic and Ablation Catheter. This proprietary catheter, which was co-developed by Stereotaxis and Biosense Webster, recently received FDA approval for use with the Stereotaxis Niobe® Magnetic Navigation System. This expands applications of the Stereotaxis Niobe System in the U.S. from diagnostic and device delivery procedures into the major therapeutic market for minimally invasive endocardial ablation treatment of cardiac arrhythmias. The worldwide market for these procedures is experiencing rapid growth and Stereotaxis estimates that the market currently comprises more than 400,000 procedures per year, of which approximately 70% are conducted in the U.S. During the week of January 2, Cleveland Clinic, Baptist Memorial Hospital-Memphis and St. Elizabeth's Medical Center of Boston completed a total of 15 procedures with the Stereotaxis Niobe system, including successful completion of complex AVNRT ablation, AV node ablation, Atrial Tachycardia Ablation and treatment of Wolff-Parkinson-White Syndrome, as well as a number of Bi-Ventricular pacing lead placements for treatment of Congestive Heart Failure. The Cleveland Clinic procedures, which included a complex atrial tachycardia, were successfully completed in the Cleveland Clinic's department of Cardiovascular Medicine, section of Electrophysiology and Pacing, which is co-chaired by Dr. Andrea Natale, M.D., and Patrick Tchou, M.D. Dr. Tchou performed the ablation utilizing Stereotaxis' Niobe Magnetic Navigation system to successfully complete the ablation.
"Until today, in order to map and ablate arrhythmia, it was necessary to manually advance and rotate a fairly stiff catheter in an effort to reach specific points within the heart," said Dr. Natale. "Adding computer control and automation to precisely steer soft, magnetically enabled catheters offers the potential to improve the treatment of complex arrhythmia. We look forward to treating a wide range of arrhythmias with this enhanced technology."
Eric Johnson, M.D., of Baptist Memorial Hospital, successfully completed two AV node ablations with the Stereotaxis system in combination with the Celsius RMT Diagnostic and Ablation Catheter. "The decreased procedure time and increased efficiency seen in our initial experiences using the Stereotaxis system in combination with the Celsius RMT Diagnostic and Ablation Catheter are rarely achieved when relying on manual ablation," said Dr. Johnson. "At a community hospital, speed and efficiency are obviously critical to the center's ability to increase patient volume, and I believe that leveraging this technology could be helpful in increasing patient flow."
Charles I. Hafajee, M.D., of St. Elizabeth's Medical Center commented, after completing successful ablation procedures with the Celsius RMT Diagnostic and Ablation Catheter, "I am very impressed with the combination of the Stereotaxis system and the new mapping and ablation catheters. The system is intuitive, user-friendly and enables us to reproduce accurate and detailed maps of cardiac anatomy."
Physicians in Europe have been able to utilize the Celsius RMT Ablation Catheter with the Niobe system since CE Mark authorization was received in March 2005 and have conducted successful ablation procedures for a variety of arrhythmias, including Wolff-Parkinson-White Syndrome, AVNRT and AVRT.
The Niobe system utilizes a computer-controlled magnetic field to remotely steer a magnetic catheter or other device through the vasculature to the target therapy site and to apply therapy with precision and efficiency, utilizing sophisticated integration of major imaging technologies. Additionally, clinical feedback indicates that use of the Niobe system reduces physician exposure to imaging radiation during procedures and that the system enhances patient safety because the consistent, "soft-touch" contact with the heart wall unique to magnetically enabled catheters may reduce the risk of vessel or other tissue perforation during procedures. The core components of the Stereotaxis system have received regulatory clearance in the U.S. and Europe.
"The use of magnetic navigation to precisely control the therapeutic tip of soft ablation catheters is a fundamental improvement over the existing practice of physicians manually controlling devices that are difficult to manipulate," said Bevil Hogg, President and CEO of Stereotaxis. "We firmly believe that Stereotaxis has the potential to become the new standard of care for both routine and highly complex ablation and other cardiac procedures."
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. Celsius is a registered trademark of Biosense Webster, Inc.
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