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News

Magnetic irrigated catheter used for first atrial fibrillation procedures in Europe

Stereotaxis : 08 September, 2008  (Company News)
The first atrial fibrillation procedures using Stereotaxis’ re-introduced partnered magnetic irrigated catheter have successfully been performed in Europe.
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.

Also in July, the company's partner submitted a PMA Supplement to the US Food and Drug Administration (FDA) for use of the magnetic Catheter in the USA with the expectation that US approval would be obtained subsequent to the European CE Mark.

Prof Carlo Pappone MD, PhD, FACC, performed the first procedures last week at San Raffaele University Hospital in Milan, Italy. Prof Pappone said, '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.'

'We are very pleased with the successful initial experience of our partnered magnetic Catheter following its recent re-introduction in Europe,' said Bevil Hogg, chief executive officer of Stereotaxis. 'We remain optimistic regarding the timing for re-approval of this Catheter in the USA and look forward to the completion of its initial evaluation prior to commercial release in Europe. Most importantly, we anticipate that the commercial re-introduction of this catheter, which is used primarily for complex procedures in the left atrium of the heart, will mark a point of inflection in the utilisation of our installed base of Niobe systems, resulting in a substantial increase in procedure volume over time and a concomitant acceleration of system sales.'
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