Healthcare Industry News: Niobe
News Release - November 6, 2006
Stereotaxis Announces Clearance of Stereotaxis System for Use in Neurovascular and Peripheral ApplicationsST. LOUIS, Nov. 6 (HSMN NewsFeed) -- Stereotaxis, Inc. (Nasdaq: STXS ) today announced 510(k) FDA clearance of the Niobe® magnetic navigation system for use in neurovascular and peripheral applications with the Company's family of Cronus® magnetically enabled .014" vascular guidewires. Stereotaxis had previously received FDA clearance to use the Niobe System and Cronus guidewire family in coronary vasculature procedures only.
"While we have no current plans to immediately move into peripheral and neurovascular clinical applications, this clearance provides us with the flexibility to do so at a time of our choosing," said Bevil Hogg, President and Chief Executive Officer of Stereotaxis, Inc. "We believe this latest clearance is further evidence of the broad applicability of our system to the entire body."
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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