ST. LOUIS, May 6, 2014 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (Nasdaq:STXS) today announced several firsts for its eleventh appearance at the annual Heart Rhythm Society (HRS) Scientific Sessions, to be held May 7-10, 2014 in San Francisco, CA. With a central theme of "Efficiency Established; Outcomes Proven; Safety Undoubted," the Company will share new clinical evidence around efficiencies achieved through its Epoch™ Solution, showcase a seminal feature of its latest generation user interface and, for the first time, present the value of its Vdrive™ Robotic Navigation System to a U.S. audience.
"The electrophysiology (EP) community has long recognized Stereotaxis as world-class in safety and efficacy," said William C. Mills, Stereotaxis Chief Executive Officer. "Through an internal study, we now have evidence of significant improvement in procedure efficiency (as measured by achievable total procedure time and ablation time) and an accelerated learning curve using the Niobe® ES Magnetic Navigation System. Until now, the claim that a proficient Niobe user can often perform faster ablation procedures compared to alternative EP treatments has been largely anecdotal. This information provides a baseline for substantiation of improved efficiency as we continue to deliver advances in robotic EP ablation."
Among the innovations Stereotaxis is launching at HRS is a key feature of the Company's enhanced user interface for the Epoch platform. As its name indicates, Ablation History provides a history of the catheter's power output and duration of energy application at each location during the ablation through an intuitive graphical display. With this feature, physicians can retrace their ablation-related activity and potentially identify gaps in lesion lines on a real-time basis. The Company believes this additional capability will assist physicians in visualizing the applied treatment, reducing the need for touch-up at the end of the procedure and minimizing unnecessary tissue injury, which should lead to improved procedure efficiency and outcomes. Physicians will have the opportunity to see the feature in a live simulation lab at the Stereotaxis booth.
Ablation History is the latest capability offered through a platform that has been utilized in approximately 70,000 robotic EP procedures to date. More than 500 EP physicians worldwide currently rely on Stereotaxis technology, which includes the Niobe system, Vdrive system and accessory disposables, and the Odyssey® Information Management Solution. The Vdrive robotic navigation system is a relatively new offering in the U.S., receiving FDA clearance of its V-Sono™ ICE Catheter Manipulator in July 2013. Now installed in nine U.S. sites, the system has aided in more than 100 Niobe procedures. In addition, the V-Loop™ Variable Loop Catheter Manipulator has been submitted for FDA clearance. This year represents the first opportunity the Company will have to formally present the features and benefits of the Vdrive system to HRS participants.
During a breakfast symposium held at the HRS Rhythm Theatre on May 8 at 6:30 a.m. and moderated by Stereotaxis Chief Medical Officer Dr. Gery Tomassoni, two renowned EP physicians and researchers, Dr. Hiroshi Nakagawa (University of Oklahoma Health Sciences Center) and Dr. Eugene Crystal (Sunnybrook Health Sciences Centre, Toronto), will speak to the unique clinical value and procedure efficiency achieved with Stereotaxis solutions.
In addition, the following physicians will be on hand at the Stereotaxis booth (Booth 2002) to engage with participants on building a successful Stereotaxis program:
Erik Wissner, M.D., Ph.D., Asklepios Klinik St. Georg (Hamburg, Germany) – May 8, 9:30 a.m.
J. David Burkhardt, M.D., Texas Cardiac Arrhythmia Institute (Austin, TX) – May 8, 10:00 a.m.
Sabine Ernst, M.D., Ph.D., Royal Brompton Hospital (London, England) – May 9, 10:00 a.m.
Aseem Desai, M.D., Mission Hospital (Mission Viejo, CA) – May 9, 11:00 a.m.
Furthermore, HRS scientific proceedings will feature a series of abstracts and posters with the latest clinical data related to Stereotaxis technologies, including:
"Catheter Ablation of Ischemic Ventricular Tachycardia with Remote Magnetic Navigation STOP VT Trial (Study to Obliterate Persistent Ventricular Tachycardia);" Jan Skoda, et al.
"Creation of Complete Conduction Block Across the Mitral Isthmus Using Magnetic Catheter Maneuvering System: Importance of Magnetic Field Direction for Ablation Within the Coronary Sinus;" Hiroshi Nakagawa, et al.
"The Impact of Pulmonary Vein Diameter on Freedom from Atrial Fibrillation Using Remote Magnetic Navigation for Circumferential Pulmonary Vein Isolation;" Leonard Bergau, et al.
"Remote Magnetic Navigation versus Manual Navigation for Irrigated Point-by-Point Radiofrequency Ablation of Paroxysmal Atrial Fibrillation: Comparative 3-Year Data;" Frederick T. Han, et al.
"Maintenance of Sinus Rhythm Following Ablation of Persistent and Long-Standing Persistent Atrial Fibrillation: An Achievable Goal!;"Harish Manyam, et al.
"Successful Ablation of PVCs Emanating from an Immediate Parahisian Location using Remote Magnetic Navigation and an Open Irrigated Catheter;"Jose Cuellar, et al.
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 collaboration of life-saving 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 has received U.S. clearance, and the V-Loop™ variable loop catheter manipulator has been submitted for review by the U.S. Food and Drug Administration. 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, the outcome of various shareholder litigation filed against Stereotaxis, 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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