FDA panel gives cautious nod to the Watchman

The FDA’s Circulatory System Devices Panel voted 7-5 in favor of the Watchman, an implantable device that blocks the left atrial appendage with a fabric-covered expandable nitinol cage. It is designed to help patients with nonvalvular AF avoid warfarin therapy.

You can read a Heartwire story, a MedPage story, or a Reuters story.

You can read links to additonal coverage about the device in our previous story.


  1. […] Results of PROTECT AF were initially presented in March at the ACC and the device received a cautious approval recommendation from an FDA advisory panel a month […]

  2. […] reviews from the FDA staff, though it eventually received a positive, though hardly unanimous, vote of approval from the FDA’s Circulatory System Devices Panel. Publication of the trial in the Lancet was […]

  3. […] fibrillation. Although the  earlier pivotal PROTECT AF trial received a positive, though lukewarm endorsement from the FDA’s Circulatory System Devices Panel, the FDA ultimately said Boston […]

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