FDA News

Stereotaxis Announces FDA Approval of Partnered 8mm Ablation Catheter

(April 5, 2007)--Stereotaxis announced hat 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, MD PhD, FACC, Director of the Arrhythmology Department.

Bevil Hogg, CEO of Stereotaxis, stated, "We are very excited about the completion of these important milestones. U.S. regulatory approval of the 8mm catheter for ablation, combined with successful clinical experience in Europe, dramatically increases the clinical applications of magnetic navigation for complex EP procedures. We look forward to further increasing clinical utilization with the expected release later this year of the irrigated magnetic catheter, which has been submitted for European and FDA regulatory review."

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