Healthcare Industry News: Niobe
News Release - October 3, 2007
Stereotaxis Highlights New Data on Acute Success in AFib Treatments With Niobe Magnetic Navigation System93% Acute Success Rate for Catheter Ablation Procedures Performed with Niobe Reported at European Society of Cardiology Congress
ST. LOUIS, Oct. 3 (HSMN NewsFeed) -- Stereotaxis, Inc. (Nasdq: STXS) today highlighted a presentation by Xu Chen, M.D., of the Rigshospitalet at the University of Copenhagen, that reported a 93% acute success rate in patients treated for atrial fibrillation with the Niobe® magnetic navigation system. Dr. Chen presented the data at the recent European Society of Cardiology Congress (ESC) in Vienna.
Dr. Chen's presentation focused on his use of catheter ablation to treat 42 patients with atrial fibrillation. In all cases, Dr. Chen guided the catheters with the Niobe magnetic navigation system, controlled from his remote station adjacent to the procedure room. In 93% of these cases the pulmonary veins were fully isolated from the left atrium, eliminating the main cause of the arrhythmia.
On average, these 42 procedures lasted slightly less than 2 1/2 hours, which compares very favorably to manual procedures, and the patients averaged less than 10 minutes of x-ray exposure. Patients and physicians alike can commonly expect up to an hour of x-ray exposure during a manual procedure, according to published reports.
"We have performed more than 250 total cases with the Stereotaxis system," said Dr. Chen. "The ESC presentation was based on our first series of complex ablations and since then we have performed an additional 68 complex cases. We have had zero complications, and fluoro time in the last 50 cases has dropped to five minutes per procedure. Procedures with the Stereotaxis system are faster and far more precise than I could perform with my hands. We are incredibly happy with the system's performance."
Jeffrey Olgin, MD, Chief of Cardiac Electrophysiology at the University of California, San Francisco, said, "UCSF is treating complex procedures on virtually a daily basis with the Stereotaxis system, with clinical results similar to Dr. Chen's. The system has made complex left-sided procedures easier, and we expect it will become the new standard of care for complex and left-sided ablation procedures."
Using magnetic fields and sophisticated computer guidance, the Stereotaxis system is capable of very precise and accurate movements in the most sensitive areas of the heart, and of maintaining the catheter's gentle, consistent contact with the beating heart's surface. This consistent contact allows the physician to deliver ablation energy safely and effectively to treat a broad range of arrhythmias.
"We have tracked the performance of our system in more than 10,000 cases, including approximately 2,000 atrial fibrillation and other complex procedures," said Bevil Hogg, CEO of Stereotaxis. "We are very pleased with the success rates we are achieving with our currently available catheters. Significantly, our incidence of catheter related complications associated with complex left-sided procedures stands at approximately 0.1%, representing what we estimate to be a greater than fifty-fold improvement over what has been reported by the Heart Rhythm Society for manual AF cases. Stereotaxis has the only robotic navigation system cleared by the FDA for remote ablation procedures, and we are proud of Dr. Chen's and Dr. Olgin's work, which, together with the contributions of physicians at more than 60 sites worldwide, underscores our growing reputation for safety, efficacy and precision."
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. The use of cardiac ablation catheters for treatment of atrial fibrillation is considered investigational in the United States.
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