ST. LOUIS, June 01, 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 retrospective study conducted at Paracelsus Medical University in Nuremberg, Germany, which showed significantly reduced radiation exposure for patients undergoing catheter ablation for persistent atrial fibrillation (AF) with the Niobe® magnetic navigation system. The study received first place honors for “Best Poster Presentation” at the European Cardiac Arrhythmia Society Congress in Paris.
“We utilize the Niobe system daily and trust it implicitly to improve the safety and efficacy of ablation procedures for atrial fibrillation, ventricular tachycardia and other complex cases,” said Dirk Bastian, MD, electrophysiology specialist at Paracelsus Medical University, Nuremberg. “The data collected from these procedures further demonstrate the significantly reduced fluoroscopy times that can be achieved through the Niobe system’s remote navigation and image integration capabilities, minimizing radiation exposure to both the patient and operator, and also reflect excellent acute and long-term results with minimal complications. We are very pleased to share these important findings as we continue our pledge to provide the highest patient care through innovative medical technologies.”
The study analyzed data on 169 patients with symptomatic, persistent AF undergoing catheter ablation with the Niobe system, documenting fluoroscopy time for system calibration, transseptal access/catheter positioning and mapping/ablation. Total fluoroscopy time was 5.1±3.8 minutes, compared to an average of 14 to >60 minutes reported for traditional manual ablation procedures, and the effective radiation dose was 0.61±0.9 millisieverts (mSv) compared to the typical mean effective dose of 16.6 mSv reported for manual procedures, representing a 96% reduction.
The Nuremberg hospital, one of the largest in Europe, installed the Niobe system as part of its new Heart-Vascular Center. Konrad Göhl, MD and Dirk Bastian, MD were trained on the Niobe system in 2011 and have completed more than 1,000 ablation procedures on the remote magnetic navigation platform. The department of electrophysiology will complete the 12 month follow-up on approximately 600 patients undergoing AF ablation with the Niobe system and analyze the data regarding efficacy, safety and radiation exposure for the total population as well as several subgroups (Remote MAGNetic Catheter Ablation for Atrial Fibrillation – MAGNA-AF, ClinicalTrials.gov Identifier: NCT02587624).
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® magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management solutions, 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.
Martin C. Stammer
Chief Financial Officer
Todd Kehrli / Jim Byers
MKR Group, Inc.