Healthcare Industry News: Stereotaxis
News Release - February 27, 2009
Stereotaxis Announces FDA Approval of the NAVISTAR(R) RMT THERMOCOOL(R) CatheterST. LOUIS, Feb. 27 (Healthcare Sales & Marketing Network) -- Stereotaxis, Inc. (Nasdaq: STXS ) announced today that the U.S. Food and Drug Administration approved for marketing the NAVISTARŽ RMT THERMOCOOLŽ Catheter, which is manufactured by Biosense Webster, Inc, a Johnson & Johnson company. The NAVISTARŽ RMT THERMOCOOLŽ Catheter is used with Stereotaxis' NIOBEŽ Remote Magnetic Navigation System for mapping and radiofrequency (RF) ablation to treat irregular heartbeats, or cardiac arrhythmias. Stereotaxis expects that shipments of the catheter to customers will begin within the next few weeks.
"This important milestone will provide our customers an expansion of system capabilities through the availability of a broad set of magnetic devices which address the many needs of patients in all chambers of the heart," added Mr. Kaminski. "We are confident that this product introduction will be transformative for our company."
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 and elsewhere.
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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.
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