FDA Advisory Panel Recommends Approving First-of-its-Kind AFib Device

Heart of Health Policy | An U.S. Food and Drug Administration (FDA) advisory committee has overwhelmingly recommended approval of the Watchman Left Atrial Appendage Closure Technology. The FDA’s Circulatory System Devices Panel convened in December to review data from two studies conducted to evaluate the device’s safety and effectiveness, as well patient registry data. At the end of the daylong meeting, the panel voted 13-1 on each of three key questions related to safety, effectiveness and benefit-risk calculus. The FDA will have the final say on if the device will hit the market.

Additional FDA Updates

  • The FDA has approved Farxiga for patients with type 2 diabetes The FDA has relaxed prescription use and restrictions for Avandia
  • The FDA is investigating the type 2 diabetes drug saxagliptin due to a possible link to heart failure
  • The FDA is investigating cardiovascular risk in FDA-approved testosterone products
  • The FDA has warned of possible complications associated with exceeding sodium phosphate dosage recommendations
  • An FDA Advisory panel has recommended that naproxen labels should not include a cardiovascular safety claim
  • An FDA advisory panel has voted against approving rivaroxaban for patients with acute coronary syndromes

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Keywords: Equipment Safety, Registries, Atrial Appendage, United States Food and Drug Administration, Calculi, Advisory Committees, Cardiology Magazine, ACC Publications

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