Healthcare Industry News:  magnetic navigation 

Devices Cardiology FDA

 News Release - January 15, 2008

Stereotaxis Announces FDA Approval of Its Partnered Magnetic Irrigated Catheter

Important Milestone for Treatment of Complex Arrhythmias Achieved

Approval Considered Transformative for Stereotaxis Business Model


ST. LOUIS, Jan. 15 (HSMN NewsFeed) -- Stereotaxis, Inc. (Nasdaq: STXS ) announced today that the Company has been advised that the U.S. Food and Drug Administration (FDA) has approved its partnered magnetic irrigated catheter for use in mapping and ablation in the United States.

"The long-awaited FDA approval of our partnered irrigated catheter is a very significant milestone for Stereotaxis," said Bevil J. Hogg, Chief Executive Officer of Stereotaxis. "Since its approval and introduction in Europe, the irrigated catheter has been used to successfully treat complex left-sided arrhythmias at a number of leading hospitals in Europe. Patient outcomes have been excellent. The Stereotaxis magnetic navigation System, used in conjunction with the magnetic irrigated catheter and the Company's latest software release has performed extremely well with a high degree of safety. We believe that these results will be duplicated at centers in the U.S., and we are confident that the Stereotaxis magnetic navigation System with the irrigated catheter has the potential to establish a new standard of care in the treatment of complex arrhythmias. A broad spectrum of thought leaders will present their initial experience with the magnetic irrigated catheter in European centers during the Boston Atrial Fibrillation Symposium on January 17 and 18, and we eagerly look forward to their presentations.

"There is significant pent-up demand for our solution among both existing and prospective customers," continued Mr. Hogg. "As a result, once the irrigated catheter becomes broadly available in the U.S., we anticipate a return to strong pipeline and order growth for our magnetic navigation System and accelerated growth in usage rates and related recurring revenues. We are highly confident that this momentum will be transformative for our company."

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.

About Forward Looking Statements

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 for 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.


Source: Stereotaxis

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