FDA to Review Atritech Watchman Device As Alternative to Warfarin or Coumadin in Preventing Strokes
Posted Apr 21 2009 11:54am
Recently we reported on the results of the Watchman device trial as an alternative to Coumadin or warfarin in the prevention of strokes among those with atrial fibrillation. We mentioned that it would be reviewed by the FDA Advisory Committee on April 23, 2009.
In advance of the review meeting on Thursday, the FDA has just released their documents and opinions. We’ve updated our story to include the FDA opinions (they may surprise you) and a link to all briefing documents from both the FDA and the sponsor, Atritech. You’ll find the Update at the bottom of this article:
Are you planning to attend the FDA Advisory Committee meeting on Thursday in Gaithersburg, MD, and would you be willing to tweet from it via Twitter? If so, please let us know and we’ll follow your tweets and retweet them to the afib community on Twitter.