ST. LOUIS, May 1 /PRNewswire-FirstCall/ -- Stereotaxis, Inc. (Nasdaq: STXS), announced today that approximately 15,000 procedures have been performed using Stereotaxis' Niobe(R) Magnetic Navigation System. The Niobe System has been used to perform procedures in all four chambers of the heart and in every type of cardiac patient, from pediatric to geriatric, with exemplary precision, efficacy and safety. Most notably, major adverse events directly attributable to the use of the Magnetic Navigation System have occurred in fewer than 0.1% of the approximately 15,000 cases, which include over 3,500 complex electrophysiology procedures.
A total of 87 peer-reviewed publications on magnetic navigation have appeared since the inception of Niobe, showing excellent results ranging from 98.6% chronic success for SVT, to 76% chronic success for life-threatening ischemic VT.
"In my career, I have had the opportunity to evaluate a great deal of new technology," said Dr. J. David Burkhardt, Chief Medical Officer of Stereotaxis, and formerly of The Cleveland Clinic Foundation, where he performed more than 300 cases using the Stereotaxis Niobe System, as well as a number of cases with competing technology. "Most devices are designed for a particular procedure. The unique quality of the Stereotaxis system is its ability to perform any interventional electrophysiology procedure in any chamber of the heart. The system also has the ability to navigate those catheters from any approach, not just the standard femoral vein access site. In essence, this is the only new technology that can replace the manual skills of the ablationist for every procedure. For the Interventional Cardiologist or implanters of Cardiac Resynchronization Therapy devices, the ability to control the tip of the wire and navigate it through any blood vessel from any approach is also unique. In addition, I am amazed by the low frequency of major complications. We are continuing to learn about the importance of pressure in complications such as steam pop, perforation and atrial-esophageal fistula. The ability of this system to navigate and ablate without producing dangerous pressures, certainly seems to contribute to its safety record."
"With nearly 100 installations worldwide, we are extremely pleased that the Niobe system has maintained such a remarkable record for safety and efficacy, given the large and diverse group of clinicians using the system," said Bevil Hogg, CEO of Stereotaxis. "As the Niobe's reputation for success and safety continues to spread, we believe that informed patients will begin to self-refer to centers that have the Niobe System when seeking treatment for their complex arrhythmias, and that the Niobe System will enable clinicians to confidently perform cardiac ablations in areas of the heart once thought unreachable or potentially unsafe with manual techniques or alternative technologies."
"We look forward to introducing our new Navigant 3.0 software platform at HRS, the development of which has benefited from the collective experience of hundreds of users of our system over the many thousands of cases done," Mr. Hogg added. "We believe Navigant 3.0 will accelerate adoption of our Niobe system as a new standard of care in the treatment of complex arrhythmias by expanding its automated features and 3D capabilities while greatly simplifying ease of use."
Navigant 3.0, is the next generation user interface software for Niobe, and it will provide users with a significant number of enhanced features and new capabilities ranging from much simplified ease of use, including automated registration of a partner's mapping system as well as faster and more accurate automation with re-targeting to compensate for patient movement, coupled with comprehensive recall of previous catheter locations. Stereotaxis will demonstrate Navigant 3.0 in its Booth #304 at Heart Rhythm 2008 to be held from May 14 to 17 at the Moscone Center in San Francisco. Navigant 3.0 is expected to be commercially available toward the end of 2008 and Stereotaxis believes that, particularly when used in combination with Odyssey, it will significantly advance EP lab productivity and procedural workflow management.
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.
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, continued acceptance for the Company's products in the marketplace, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, 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 or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.
SOURCE Stereotaxis, Inc.