ST. LOUIS, March 11, 2016 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced that the Journal of Cardiovascular Electrophysiology (http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1540-8167), a publication of Wiley Periodicals and a leading peer-reviewed journal devoted to the study of electrophysiology (EP) of the heart, has published a special supplemental issue dedicated to Stereotaxis technology. The supplement is the first in the literature to focus solely on the Company’s Niobe® remote magnetic navigation system and features seven peer-reviewed clinical papers by more than 50 authors studying the results of the Niobe system in catheter ablation of complex arrhythmias.
Commenting on the publication, Guest Editors Drs. Andrea Natale and Hiroshi Nakagawa said, “The Niobe remote magnetic navigation system has been developed to address the limitations of traditional radiofrequency ablation, including relatively long procedure times (causing significant operator fatigue), radiation exposure for both physicians and patients, and inconsistent catheter contact which can lead to incomplete mapping and poor lesion formation. This supplement describes the impressive recent progress using the Niobe system for catheter ablation in patients with ventricular tachycardia (VT) and other complex arrhythmias.” Andrea Natale, M.D. serves as Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center; Hiroshi Nakagawa, M.D., Ph.D. is Professor of Medicine at the Heart Rhythm Institute of University of Oklahoma Health Sciences Center.
“For patients seeking treatment for complex arrhythmia in the cardiac cath lab, continuing improvements in outcomes depend on the advancement of the clinical science informing the technologies arrayed to deliver this therapy. Ever-mindful of this relationship, we are truly delighted to see remote magnetic navigation take center stage in the leading publication for the practice of electrophysiology and to share with the EP community the latest clinical data regarding the remarkable efficacy and safety that is achieved using our Niobe system,” said Mr. William Mills, Stereotaxis Chief Executive Officer. “These studies build on a constellation of more than 260 peer-reviewed articles already in the literature on the use of the Niobe system for advanced navigation and mapping, especially in complex anatomy and difficult-to-reach locations of the heart.”
The supplement features the first multicenter, prospective study evaluating mapping and ablation of post-infarction VT with the Niobe system, the first randomized controlled trial of the Vdrive® robotic navigation system compared to manual circular mapping catheter manipulation, and a study of procedural outcomes in the largest cohort of patients undergoing complex left atrial ablation to date. All papers from the supplement can be downloaded at http://onlinelibrary.wiley.com/doi/10.1111/jce.2016.27.issue-S1/issuetoc.
Complete list of studies
- “Remote Magnetic Navigation for Catheter Ablation in Patients with Congenital Heart Disease”; Lead author: Sabine Ernst, M.D., Ph.D.
- “A Comparison of Remote Magnetic Irrigated Tip Ablation versus Manual Catheter Irrigated Tip Catheter Ablation with and without Force Sensing Feedback”; Lead author: J. Peter Weiss, M.D.
- “Catheter Ablation of Ischemic Ventricular Tachycardia with Remote Magnetic Navigation: STOP-VT Multicenter Trial”; Lead author: Petr Neuzil, M.D.
- “Remote Magnetic Navigation: A Focus on Catheter Ablation of Ventricular Arrhythmias”; Lead author: Luigi Di Biase, M.D., Ph.D., F.A.C.C., F.H.R.S.
- “Safety and Long-Term Outcomes of Catheter Ablation of Atrial Fibrillation Using Magnetic Navigation versus Manual Conventional Ablation”; Lead author: Pedro Adragậo, M.D., Ph.D.
- “Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study”; Lead author: Georg Nӧlker, M.D.
- “Efficacy and Safety of Atrial Fibrillation Ablation Using Remote Magnetic Navigation: Experience from 1,006 Procedures”; Lead author: Xu Chen, M.D., M.D.Sc.
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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