ST. LOUIS, Jan. 25 /PRNewswire-FirstCall/ -- Stereotaxis, Inc. announced today that cardiologists have performed more than 6,000 clinical cases using its advanced magnetic navigation technology, including over 4,000 electrophysiology procedures (principally ablation) and more than 2,000 guidewire navigation procedures for interventional cardiology and cardiac resynchronization therapy lead placement. The company also confirmed that well over 100 orders for Niobe systems have been received since inception, and that the 50th scientific peer-reviewed publication regarding Stereotaxis technology has been published in the medical literature.
"These milestones demonstrate our substantial clinical and scientific momentum with clinicians and hospitals performing cardiac procedures. They indicate that the value of our technology is broadly recognized in the areas of safety, efficacy and efficiency," said Bevil Hogg, President and CEO of Stereotaxis. "For example, after more than 4,000 simple and complex EP procedures, we have maintained our system's perfect safety record of zero cardiac perforations attributable to our magnetic GentleTouch(TM) catheters." The rate of cardiac perforations with manual technology in the medical literature ranges from 0.7% in simple ablations, to over 2.4% in complex ablations. Another important safety consideration is radiation exposure to patients. Two large multi-center studies using Stereotaxis technology have shown a significant reduction in radiation exposure to patients.
"Importantly," continued Mr. Hogg, "the efficacy of Stereotaxis' technology in performing ablations of arrhythmias has been validated in a 156 patient study, performed for an FDA PMA submission, which reported a long-term success rate greater than 98%, the highest such rate ever reported in published PMA summaries for ablating these arrhythmias. These results underline the value of our GentleTouch(TM) technology in creating optimal lesions for long term success, while maintaining an exemplary safety profile."
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.
Forward Looking Statement
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.
Contacts: Stereotaxis, Inc. 314-678-6105 Jim Stolze, Chief Financial Officer jstolze@stereotaxis.com Noonan Russo Matt Haines (investors) 212-845-4235 Noonan Russo Ben Carmichael (media) 212-845-4242
Stereotaxis, Inc.CONTACT: Jim Stolze, Chief Financial Officer, Stereotaxis, Inc.,+1-314-678-6105, jstolze@stereotaxis.com; Matt Haines (investors), NoonanRusso, +1-212-845-4235; Ben Carmichael (media), Noonan Russo,+1-212-845-4242
Web site: http://www.stereotaxis.com/
