ST. LOUIS, April 07, 2016 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced the results of a long-term follow-up study on the efficacy of the Stereotaxis Niobe® ES magnetic navigation system reported by Lund University Hospital in Sweden, which validate improved long-term clinical outcomes compared to manual navigation for ablation treatment of atrial fibrillation (AF). The study, presented as a scientific abstract at the American College of Cardiology Scientific SessionsApril 2-4, represents the first published long-term clinical outcome results achieved purely with the latest generation Niobe system in AF ablation.
Lead author Dr. Shiwen Yuan, Associate Professor of Cardiology at Lund University, commented on the study results, “Our data demonstrate that the Niobe ES system is associated with reduced fluoroscopy time and markedly improved long-term clinical outcomes in AF ablation when compared to manual techniques, validating our belief in this state-of-the-art interventional technology. The Niobe system enables enhanced cardiac mapping, precise catheter positioning, access to difficult-to-reach anatomy, and significantly lower radiation exposure–all critical factors in achieving safe and effective transmural lesions.”
In the study, 112 consecutive AF patients were ablated utilizing the Niobe system versus 102 patients with manual navigation. The Niobe patient group experienced significantly shorter fluoroscopy time (11.1±6.3 vs. 16.9±10.8 min, P <0.05) and fewer major complications (1 significant PV stenosis vs. 3 tamponades) than the manual patient group. Furthermore, after 33±8/42±9 months of follow-up, significantly better clinical efficacy (P <0.05) was found in the Niobe group (AF free or markedly improved: 64% after 1st and 81% after 2nd ablation, respectively) than in the manual group (52% after 1st and 67% after 2nd ablation, respectively).
“On a personal note, the convenience and ease of use associated with the Niobe system alleviates much of the physical burden related to these complex procedures, enabling me to continue practicing electrophysiology longer than expected,” said Dr. Yuan, who performed his first procedure using the Niobe system in late 2011 and has since completed more than 300 cases. Collectively, physicians at Lund University Hospital perform over 100 ablations annually utilizing the Niobe system.
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis' core Epoch® Solution includes the Niobe® ES remote magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management systems, and the Vdrive® robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received clearance in the United States, Canada, and the European Union. For more information, please visit www.stereotaxis.com.
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, the Company's ability to raise additional capital on a timely basis and on terms that are acceptable, its continued listing on the NASDAQ Capital Market, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the United States, including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, 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, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.
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