Stereotaxis' Niobe System Used to Perform More Than 10,000 Procedures Worldwide
To date, clinicians at more than 60 hospitals worldwide have used theStereotaxis system to perform over 2,000 percutaneous coronary interventions(PCI) and other guidewire-based vascular procedures; approximately 6,000right-sided electrophysiology mapping and ablation procedures; and nearly2,000 atrial fibrillation and other complex left-sided procedures, including400 for ventricular tachycardia.
"As one of the largest electrophysiology practices in the country, weregard our Stereotaxis Niobe(R) system as an important component of our dailytreatment of a broad spectrum of arrhythmias," said Dr. Raul Weiss of OhioState University Hospital. "We are particularly impressed with the superiorperformance and safety of the system in challenging cases, and we believe thatStereotaxis will revolutionize the treatment of complex arrhythmias, setting anew paradigm for patient care."
"The strong growth in our technology's clinical utilization is occurringacross a broad range of electrophysiology, interventional cardiology, andother vascular procedures, and we are pleased to note that nearly 500procedures have been completed with our new partnered eight millimetercatheter, since its recent launch," said Bevil Hogg, CEO of Stereotaxis. "TheStereotaxis system is continuing to gain recognition from clinicians for itspeerless safety record, reflected in the fact that Stereotaxis' incidence ofall reported cardiovascular complications associated with the use of magneticcatheters for complex left-sided procedures stands at approximately 0.1%,representing what we estimate to be a greater than fifty-fold improvement overwhat has been reported by the Heart Rhythm Society for manual AF cases. Thesteady adoption of the Stereotaxis system, its increasing utilization andsafety profile, are very encouraging. With additional milestones on thenear-term horizon, we anticipate a favorable acceleration of our clinicalusage in 2008."
"We are, for instance, looking forward to the near-term launch of ourirrigated catheter in Europe, and its regulatory approval in the U.S. byyear-end," added Mr. Hogg. "We are also expecting to announce at the upcomingTCT conference, a new solution for the treatment of complex vascular lesions,including chronic total occlusions, in the coronaries and peripheralvasculature. This will further demonstrate the power of the Niobe system as aplatform which can be broadly expanded, with the potential to deliver simpler,safer, and less expensive treatments for complex cases across the full rangeof interventional practice."
Stereotaxis designs, manufactures and markets an advanced cardiologyinstrument control system for use in a hospital's interventional surgicalsuite to enhance the treatment of coronary artery disease and arrhythmias.The Stereotaxis System is designed to enable physicians to complete morecomplex interventional procedures by providing image guided delivery ofcatheters and guidewires through the blood vessels and chambers of the heartto treatment sites. This is achieved using computer-controlled, externallyapplied magnetic fields that govern the motion of the working tip of thecatheter or guidewire, resulting in improved navigation, shorter proceduretime and reduced x-ray exposure. The core components of the Stereotaxissystem have received regulatory clearance in the U.S., Europe and Canada.
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