August 18, 2017

FDA to Review Atritech Watchman Device As Alternative to Warfarin or Coumadin in Preventing Strokes From Atrial Fibrillation

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:

Watchman Device as Alternative to Warfarin or Coumadin

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.

Comments

  1. Sharon,

    I don’t have an answer yet, but have reached out to Nigel to find out how he’s doing and how the removal went.

    Mellanie

  2. Sharon Kolodzej says:

    Being two months post this patient’s situation, do you know the answers to your questions, meaning was he an early participant? Any data on the occurance rate of the device shifting?

  3. Nigel,

    My heart goes out to you. I’m so sorry about the problems you’ve had with this device.

    This is really scary. Were you one of the early participants in the clinical trial? I had read that there had been changes due to problems early in the trial, but this is horrible. I’m so sorry.

    Mellanie

  4. Nigel Grant says:

    IT GET WORSE!
    I have a Watchman device in my left atrial appendage that has moved twice and now projects into the left atrial lumen from where it threatens the mitral valve and the atrial wall itself. I am scheduled for serious on-pump open heart surgery to remove this faulty equipment. I was never warned that this might be such a risk – other than the meaningless mumbo-jumbo “informed consent” statements put on everything medical. There are others also unreported and I encourage them to come forward. This is a high-risk process and not to be entered into lightly. In the meantime, two atrial ablations have cleared up my arrhythmia – so the Watchman with its trailing razor-sharp barbs are poised to slice open my heart, destroy my mitral valve and cut open any artery it can get into – for no purpose at all. I read that one patient’s device got “lost” and was found in her abdominal aorta. Go figure.
    Nigel Grant
    Solicitor, England & Wales
    Attorney at Law, California

  5. Nigel Grant says:

    Does anyone have experience with moving or removing the Atritech Watchman? I am in the Protect-AF test and my device has shifted so that blood is flowing round the device. Comments please.

  6. Elizabeth,

    It’s great to hear from you. I’ve been thinking about you and wondering how you’re doing.

    I hope to have more info later this week and will reply then. I’m at the American Association for Thoracic Surgery conference in Boston and later this week will be at the Heart Rhythm Society conference. I was planning to spend a few minutes at HRS with folks from Atritech to get an update on the Watchman. More later.

    Mellanie

  7. Elizabeth Pappas says:

    Is this device and procedure available as of May 2009?
    Which institutions or Doctors are becoming the specialists?
    Is it true that Rochester, MN .. Mayo Clinic is leading the way?
    Is there anywhere in Texas?
    It would be a great intervention if it shows success over the next year.
    Thank you for your work in coming us updated.
    We certainly are continuously grateful.

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