March 14th, 2015

FDA Approves Watchman Left Atrial Appendage Closure Device for AF

The FDA has approved Boston Scientific’s long-delayed Watchman Left Atrial Appendage Closure Device. According to the company, the Watchman is indicated as an alternative to long-term warfarin therapy for the reduction of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation at increased risk for stroke and systemic embolism.

Although an alternative to warfarin, for patients to be eligible they must be “deemed by their physicians to be suitable for warfarin” and to have an “appropriate rationale” for preferring the device to warfarin.

Boston Scientific said the device will be available first at centers where it has been used in clinical studies. Availability will be more widespread as physicians are trained in its use.

The Watchman has a long and highly troubled history at the FDA. The FDA has postponed approval of the device on several occasions as it found numerous problems with the clinical trials exploring its use. Most recently, last October, the FDA’s Circulatory System Devices advisory panel gave the device an extremely cautious endorsement. They said the trials supporting the device, PROTECT AF and PREVAIL, clearly showed that Watchman was not equivalent to warfarin. But they also felt that the device should be made available to AF patients who were eligible for but did not want to take warfarin.


4 Responses to “FDA Approves Watchman Left Atrial Appendage Closure Device for AF”

  1. James Connelly, BS, MD says:

    What about the clots that form outside of the LAA? I have seen huge clots mimicking LA myxomas that were large clots on the interatrial septum that resolved after 2 months of anticoagulation. I guess this will help a lot but not completely protect against a CVA. I guess how does this apply in the era of the novel antiocoagulants which may make anticoagulation more palatable? I have placed nearly all of my pre NOAC era warfarin refusers on a NOAC with great ease thus negating the need for closure device. How the world turns.

  2. How about patients who are at high-risk of bleeding, or have bled a lot while on anticoagulants? Not quite the same patients as trial enrollees…

  3. Hamdy Abdalla, md says:

    it is more better than anticoagulant but very expensive and also need anticoaglant for short time.

  4. Shila Shila, MSc says:

    anticoagulants and watchman just prevent clots but they donot cure af which would lead to hf in long term. more work is needed on the cure.