ST. LOUIS, Aug. 10, 2015 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (NASDAQ:STXS) and Erasmus Medical Center in Rotterdam, The Netherlands today announced the results of a seven-year clinical study, which provides significant findings in terms of the Stereotaxis remote magnetic navigation platform's success in ventricular tachycardia (VT) ablations compared to both contact force sensing and other manual catheters.
"There is a persistent demand in the electrophysiology field for innovative technologies that reduce complications and improve success rates," said Tamas Szili-Torok, M.D., Ph.D., with the Department of Clinical Electrophysiology at Erasmus Medical Center. "Our aim was to study the long-term efficacy of contact force (CF) sensing catheters compared to other manual catheters and Stereotaxis magnetic navigation in patients with ventricular tachycardia. On several clinical endpoints – acute success, major complications and recurrence rate using an intention-to-treat analysis – the use of Stereotaxis technology provided better results than both CF and manual approaches."
A total of 239 patients who underwent VT ablation with CF catheters, other manual catheters or the Stereotaxis Niobe® remote magnetic navigation system were included in this single-center, cohort study from January 2007 until March 2014. The highest acute procedural success – 86% – was achieved in the patient group using the Niobe system, compared to a success rate of 71% for the CF and manual groups. Major complications occurred in 1.2% of Niobe patients versus 10% of CF patients and 2.7% of manual patients. Moreover, the recurrence rate was lowest in the Niobe group, which had the most rigorous follow-up time of 29 months compared to 18 and 25 months for the CF and manual groups, respectively. Overall, 42% of Niobe patients had a recurrence during follow-up, versus 59% of CF patients and 57% of manual patients. Complete study results can be accessed online in the Journal of Cardiovascular Electrophysiology (DOI: 10.1111/jce.12762, 2015).
"Our findings support the benefits of the Niobe system's maneuverability in difficult to reach anatomical areas and improved catheter stability to produce better long-term outcomes in complex ablation cases," concluded Dr. Szili-Torok.
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 U.S., 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 U.S., 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 U.S., 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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