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Stereotaxis Niobe Magnetic Navigation Systems performs 15,000 procedures

Stereotaxis : 01 May, 2008  (Company News)
Approximately 15,000 procedures have now been performed using Stereotaxis' Niobe 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 paediatric 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 percent 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 results ranging from 98.6 percent chronic success for SVT, to 76 percent 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-oesophageal 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, chief executive officer 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 centres 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,' 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, 2008 at the Moscone Center in San Francisco, USA. 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.
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