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During the external evaluation, clinicians at nine centers in Europe andCanada performed 92 procedures with the magnetic irrigated catheter,approximately 75% of which were complex left-sided procedures. The catheterexceeded all clinical end points tested during this evaluation period.Additionally, mean time to complete mapping and ablation was 20% belowdocumented manual times, and the catheter demonstrated an exceptional safetyprofile.
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Dr. Gerhard Hindricks of Herzentrum Leipzig GmbH in Leipzig said, "As oneof the original evaluation sites for the magnetic irrigated catheter, we wereamong the first to see its clear clinical advantages. Having now performedadditional cases since its re-introduction, we're delighted by its performancerelative to navigation and lesion formation and we're very excited toparticipate in its commercial release."
Dr. Karl Heinz-Kuck from St. Georg Allgemeines Krankenhaus in Hamburgsaid, "Its superb maneuverability provides precise positioning even at sitesdifficult to reach within the heart, and together with the catheter'sstability this led to a high success rate."
"With these very positive results from the external evaluation andfeedback from participating clinicians, we are very excited about thecommercial release of the magnetic irrigated catheter in the EU," said MikeKaminski, Stereotaxis President and COO. "We are confident that the launch ofthe magnetic irrigated catheter in Europe will be followed by the U.S. launch,which will result in a significant increase in Niobe utilization rates thatwill drive our future commercial momentum. Our goal is to create a newstandard-of-care for complex EP ablations."
"We have seen significant momentum in our overall position in Europe thisyear, both in terms of systems placed and orders, and this is clearly centeredon improvements in utilization around the use of the irrigated catheter," saidBevil Hogg, Stereotaxis CEO. "We expect demand will climb as the magneticirrigated catheter is launched beyond the initial nine commercial sites."
About Stereotaxis
Stereotaxis designs, manufactures and markets an advanced cardiologyinstrument control system for use in a hospital's interventional surgicalsuite to enhance the treatment of coronary artery disease and arrhythmias.The Stereotaxis System is designed to enable physicians to complete morecomplex interventional procedures by providing image guided delivery ofcatheters and guidewires through the blood vessels and chambers of the heartto treatment sites. This is achieved using computer-controlled, externallyapplied magnetic fields that govern the motion of the working tip of thecatheter or guidewire, resulting in improved navigation, shorter proceduretime and reduced x-ray exposure. The core components of the Stereotaxissystem 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-lookingstatements inherently involve risks and uncertainties that could cause actualresults to differ materially from the forward-looking statements. Factorsthat would cause or contribute to such differences include, but are notlimited to, continued acceptance for the Company's products in themarketplace, competitive factors, changes in government reimbursementprocedures, dependence upon third-party vendors, and other risks discussed inthe Company's periodic and other filings with the Securities and ExchangeCommission. By making these forward-looking statements, the Companyundertakes no obligation to update these statements for revisions or changesafter the date of this release. There can be no assurance that the Companywill recognize revenue related to its purchase orders and other commitments inany particular period or at all because some of these purchase orders andother commitments are subject to contingencies that are outside of theCompany's control. In addition, these orders and commitments may be revised,modified or canceled, either by their express terms, as a result ofnegotiations, or by project changes or delays.Company Contact: Jim Stolze Chief Financial Officer 314-678-6105 Investor Contact: EVC Group, Inc. Doug Sherk & Jenifer Kirtland 415-896-6820 Media Contact: EVC Group, Inc. Steve DiMattia 646-201-5445
SOURCE Stereotaxis, Inc.
