ST. LOUIS, Nov. 17, 2015 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced the results of an independent multicenter study on the procedural benefits and outcomes of patients undergoing radiofrequency ablation therapy for ventricular tachycardia (VT) using the Niobe® remote magnetic navigation system compared to manual catheter approaches. The study findings, which were recently published at the American Heart Association Scientific Sessions, represent the most significant long-term outcomes to date with the Niobe system in VT and were considerably better than those in the manual catheter group.
“This study further supports the strength of the Niobe system in effectively finding and eliminating even the most difficult to treat arrhythmias,” said Andrea Natale, M.D., FACC, FHRS, Executive Medical Director of Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center. “Most notably, our findings revealed a substantially greater long-term success rate among the Niobe patient group – 81.2% compared to 69% for the manual catheter group – which we attribute to the system’s exceptional mapping capabilities and catheter tip control, enabling operators to accurately pinpoint, access and thoroughly ablate the affected scar area.”
J. David Burkhardt, M.D. of the TCAI at St. David’s Medical Center, who recently completed his 1,000th case with the Niobe system, added, “With manual ablation, VT procedures are time consuming and the outcomes might be adversely affected by operator fatigue. We continue to rely on the Stereotaxis platform to deliver the outstanding results our patients expect and deserve.”
The retrospective study reported on a total of 218 consecutive patients with ischemic cardiomyopathy and scar size greater than 60 cm2 undergoing VT ablation in multiple centers. Eighty patients were treated with manual ablation and 138 patients underwent ablation with the Niobe system. Substrate mapping and an ablation technique utilizing scar homogenization were performed, with the end point of elimination of all abnormal electrograms within and around the scar area. The density of mapping was higher (p<0.001) and the mean mapping time was lower (p<0.001) in the Niobe group when compared to the manual ablation group. Moreover, while acute success was achieved in 99.5% of all patients, at 15±6.8 month follow-up, 81.2% of patients in the Niobe group were VT recurrence free compared to 69% of the manual catheter patient group (p=0.037).
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 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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