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[STXS] Stereotaxis, Inc.

Symbol: STXS
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9/8/2008 06:30am
Stereotaxis, Inc. Reports inital successful procedures with recently re-introduced magnetic irrigated catheter

- 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 Co's partner in July 2008, and these first cases are part of the standard pre-release evaluation.
- Also in July, the Co's partner submitted a PMA Supplement to the U.S. 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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