September 8, 2008 - Stereotaxis Inc. said today the first atrial fibrillation procedures using its re-introduced partnered magnetic irrigated catheter were successfully performed in Europe last week.
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.
In July, the company’s partner submitted a PMA Supplement 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.
“I am delighted with the results of my first procedures performed successfully with the newly available Biosense magnetic irrigated catheter,” said Carlo Pappone, M.D, Ph.D., FACC, who performed the first procedures last week at San Raffaele University Hospital in Milan, Italy. “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.”
The catheter is used primarily for complex procedures in the left atrium of the heart.
For more information: www.stereotaxis.com