First Procedures Performed with Re-introduced Biosense Catheter Deemed Successful


September 8, 2008

September 8, 2008 - The first atrial fibrillation procedures using Stereotaxis’ re-introduced partnered magnetic irrigated catheter were successfully performed in Europe last week, the company announced today.
Prof. Carlo Pappone M.D., Ph.D., FACC, performed the first procedures at San Raffaele University Hospital in Milan, Italy. "I am delighted with the results of my first procedures performed successfully with the newly available Biosense magnetic irrigated catheter. I am extremely happy with its performance, and believe that Biosense did an excellent job. Contact stability, lesion quality and overall mechanical performance are excellent, and I believe safety is likely to be exemplary," Dr. Pappone said.
The catheter received CE Mark approval in the last week of August following its resubmission to European regulators by the Company's partner in July 2008, and these first cases are part of the standard pre-release evaluation.
The Company's partner also submitted a PMA Supplement in July to the FDA for use of the magnetic catheter in the U.S. with the expectation that U.S. approval would be obtained subsequent to the European CE Mark.
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