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St Jude Medical's device to prevent stroke misses study goal

Started by riky, March 21, 2013, 08:00:16 AM

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St Jude Medical's device to prevent stroke misses study goal

By Debra Sherman (Reuters) - A clinical trial evaluating St. Jude Medical Inc's implantable device used to prevent stroke in patients who have a common congenital heart defect failed to achieve its main goal. St. Jude, which paid for the 980-patient study, said it used the trial data to file for U.S. regulatory approval and submitted an application to the U.S. Food and Drug Administration in the fourth quarter of 2012. The device, a permanent implant, is used on people who have a hole in the wall that separates the left and right upper chambers, of the heart. ...

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