Healthcare Industry News: Niobe
News Release - January 12, 2009
Stereotaxis Annouces First CTO Crossing Procedure With RF PowerAssert(TM) Magnetic GuidewireST. LOUIS, Jan. 12 (Healthcare Sales & Marketing Network) -- Stereotaxis, Inc. (Nasdaq: STXS ) today announced the first crossing of a chronic total occlusion using the RF PowerAssert(TM) Magnetic Guidewire. Cleared by the U.S. Food and Drug Administration in 2008, the RF PowerAssert guidewire is the only magnetically enabled device available for crossing peripheral occlusions, including CTOs. Used with the Niobe Magnetic Navigation System, it is an innovative solution that enables precise intra-lesion control of its distal tip.
Austin Heart interventional cardiologist Frank Zidar, M.D. used the new device on January 7th, on a patient with severe peripheral artery disease (PAD). The patient had 100% blockage in a main artery in his leg that caused chronic, severe pain due to poor circulation.
"This new magnetic guidewire technology provided great control and improved accuracy over traditional, manual guidewires," said Dr. Zidar. "Once we reached the blockage, the tip of the guidewire burned a tiny passage through the blockage, allowing us then to use existing techniques to open up the blockage further and restore healthy blood flow to the patient's leg. This revolutionary technology will likely reduce procedures times, and therefore reduce the amount of contrast dye and imaging radiation to the patient."
Dr. Zidar performed this procedure at Heart Hospital of Austin.
"This is a promising beginning for our RF PowerAssert guidewire," said Michael P. Kaminski, Stereotaxis President and CEO. "We are delighted that Dr. Zidar was able to provide this patient with a positive outcome, and are very excited to work with other clinicians across the country as they adopt our magnetically-enabled technologies in their vascular labs."
For more information about Stereotaxis or its magnetic vascular lab technologies, visit http://www.stereotaxis.com.
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 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 the Company will recognize revenue related to its 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 the Company's 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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