April 4, 2007 — Stereotaxis, Inc. has announced that its partnered magnetically enabled 8mm ablation catheter has received FDA approval and will soon be commercially available in the U.S.
Two leading European electrophysiology centers have been building successful clinical experience using this catheter to treat atrial cardiac arrhythmias.
The 8mm catheter significantly expands electrophysiology applications for the Stereotaxis Magnetic Navigation system by providing physicians the ability to deliver high power ablations for the treatment of atrial arrhythmias. Atrial flutter, a common atrial arrhythmia estimated to represent 25% of the over 400,000 ablation procedures performed worldwide each year, is routinely treated with 8mm catheters.
Successful European cases have been completed at San Raffaele University Hospital in Milan, Italy and the Hanseatic Heart Center/St. Georg, Hamburg, Germany.
The 8mm catheter has been used at San Raffaele University Hospital for the treatment of atrial fibrillation. "The 8mm catheter is an important step toward improving the effectiveness and efficiency of atrial fibrillation procedures. The power of the 8mm catheter, combined with the safety of precise and soft contact in critical areas of the heart, simplifies the treatment of complex atrial arrhythmias," said Professor Carlo Pappone, M.D. PhD, FACC, director of the Arrhythmology Department.
Cases performed with the 8mm catheter have been very successful at the Hanseatic Heart Center/St Georg.
"The catheter allows us to deliver increased power and has been extremely effective during our preliminary experience in patients with atrial flutter," said Dr. Sabine Ernst MD. "We look forward to continue clinical ablation procedures with this catheter."
For more information visit www.stereotaxis.com.