ST. LOUIS, May 13, 2015 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (Nasdaq:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, announced today that it will participate in the 36th Annual Heart Rhythm Society (HRS) Scientific Sessions, May 14-16, 2015 in Boston, MA. During the three-day event, the Company will share new clinical evidence, technology enhancements, expert validation and interactive demonstrations of its remote magnetic navigation platform at Booth# 203.
“Our clinical sites continue to generate an abundance of data on the specific advantages of our Niobe® system compared to conventional approaches to cardiac ablation, due to the precise control, high definition mapping and enhanced linear, contiguous lesions that can be achieved during therapy,” said William C. Mills, Stereotaxis Chief Executive Officer. “We are particularly pleased to share new evidence around the clinical effectiveness of our magnetic navigation suite in the treatment of ventricular tachycardia (VT), as well as to convene a group of Stereotaxis users who will serve as lead investigators for a prospective, multi-center study to further substantiate the performance benefits of our technologies in the setting of VT.”
In the HRS Rhythm Theatre on Friday, May 15, which will be moderated by Dr. Eric N. Prystowsky (St. Vincent’s Hospital), Dr. J. David Burkhardt (St. David’s Medical Center) will present clinical data on the advantages of magnetic navigation in treating VT, specifically in the areas of contact force and lesion effectiveness, and will share his perspective that the Niobe system may become the standard of care for treatment of VT. Additionally, Dr. Hiroshi Nakagawa (Oklahoma Health Sciences Center) will discuss current scientific research on a novel approach to conducting lesion assessment without requiring contact force measurements. This research also will be presented in abstract form, “Bipolar Impedance Identifies Electrode-Tissue Contact for Radiofrequency Lesion Formation Using the Magnetic Catheter Maneuvering System in the Beating Canine Heart.”
HRS will publish several Stereotaxis related scientific abstracts, including a follow-up to a recent publication by Princess Grace Hospital in Monaco, which reported 86.6% freedom from atrial fibrillation (AF) 12 months after ablation therapy with the Niobe system in conjunction with the Vdrive® robotic navigation system. Monaco’s Dr. Gabriel Latcu will share additional results on magnetic catheter stability and optimal contact, supported by his 2015 abstract, “Magnetic and Contact-Force Sensing Catheters Have Similar Orientation During Circumferential Pulmonary Vein Isolation: Lessons From Bipolar Electrogram Morphology Analysis.” In addition, use of Stereotaxis’ Niobe system for VT procedures will be featured in an abstract titled, “Manual Navigation versus Remote Magnetic System for Ventricular Tachycardia Ablation: A Systematic Review of Literature,” by Sampath Gunda, et al., underscoring strong performance in all five clinical endpoints.
Other scientific data to be presented include:
- “Feasibility and Safety of a Novel 3-Dimensional RF Energy Monitoring System: Optimizing RF Lesion Formation to Improve AF Ablation Outcomes;" Mauricio S. Arruda, et al.
- “Vdrive™ Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study – The VERSATILE Study in Atrial Fibrillation Ablation;" Georg Noelker, et al.
Furthermore, Dr. Eric Wissner (Asklepios Klinik St. Georg) will share impressive AF outcomes and efficiency data, and Dr. Tamas Szili-Torok (Erasmus Medical Center) will unveil new evidence of increased lesion volume created by the magnetic catheter in a side-by-side comparison to a manual ablation catheter.
On the innovation front, Stereotaxis will showcase the latest version of its Navigant™ user interface, which includes enhancements to the Ablation History module that are designed to improve accuracy by compensating for movement during the respiratory cycle. In addition, for the first time, Stereotaxis will showcase the Vdrive Duo™ System featuring the V-Sono™ ICE catheter manipulator, V-CAS™ catheter advancement system and Vmotion™ automation features that improve operator efficiency by providing automatic orientation of the ICE catheter, offering a continuous view of the ablation catheter.
About Stereotaxis
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 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 U.S. clearance. The Vmotion™ automation features are available in the European Union and have 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, 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.
CONTACT: Press Contact: Martin Stammer Chief Financial Officer 314-678-6155 Investor Contact: Todd Kehrli / Jim Byers MKR Group, Inc. 323-468-2300
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