Healthcare Industry News: Niobe
News Release - November 14, 2008
Stereotaxis Announces European Commercial Release of Magnetic Irrigated CatheterST. LOUIS, Nov. 14 (Healthcare Sales & Marketing Network) -- Stereotaxis, Inc. (Nasdaq: STXS ) announced that the commercial launch of its partnered magnetic irrigated catheter will begin next week at centers in Europe. This decision to release the magnetic irrigated catheter for commercial use was made following its strong performance in the partner's recently concluded external evaluation.
During the external evaluation, clinicians at nine centers in Europe and Canada performed 92 procedures with the magnetic irrigated catheter, approximately 75% of which were complex left-sided procedures. The catheter exceeded all clinical end points tested during this evaluation period. Additionally, mean time to complete mapping and ablation was 20% below documented manual times, and the catheter demonstrated an exceptional safety profile.
Dr. Gerhard Hindricks of Herzentrum Leipzig GmbH in Leipzig said, "As one of the original evaluation sites for the magnetic irrigated catheter, we were among the first to see its clear clinical advantages. Having now performed additional cases since its re-introduction, we're delighted by its performance relative to navigation and lesion formation and we're very excited to participate in its commercial release."
Dr. Karl Heinz-Kuck from St. Georg Allgemeines Krankenhaus in Hamburg said, "Its superb maneuverability provides precise positioning even at sites difficult to reach within the heart, and together with the catheter's stability this led to a high success rate."
"With these very positive results from the external evaluation and feedback from participating clinicians, we are very excited about the commercial release of the magnetic irrigated catheter in the EU," said Mike Kaminski, Stereotaxis President and COO. "We are confident that the launch of the magnetic irrigated catheter in Europe will be followed by the U.S. launch, which will result in a significant increase in Niobe utilization rates that will drive our future commercial momentum. Our goal is to create a new standard-of-care for complex EP ablations."
"We have seen significant momentum in our overall position in Europe this year, both in terms of systems placed and orders, and this is clearly centered on improvements in utilization around the use of the irrigated catheter," said Bevil Hogg, Stereotaxis CEO. "We expect demand will climb as the magnetic irrigated catheter is launched beyond the initial nine commercial sites."
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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