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Jan 10, 2023 · Watchman devices can be worth the risk for people with NVAF. This is because the device can reduce the risk of stroke by 84% and the risk of major bleeding by 48%. However, complications can...
Sep 13, 2022 · The WATCHMAN helps reduce the chance of stroke in people with atrial fibrillation. It is an alternative to long-term therapy with blood thinners. This article explains the WATCHMAN in more detail, including who it is for, what the procedure is like, and what to expect afterward.
Oct 4, 2019 · Of nearly 3,000 adverse events reported to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database, 42% involved pericardial effusion, 11% thrombus, 5.7% cerebrovascular accident, and 5% device embolization. There were also about 211 deaths.
Oct 18, 2021 · The rates and distribution of major complications were comparable to those reported in the key clinical trials of the Watchman device, but the incidence of pericardial effusion was lower. In March 2015, the FDA approved the Watchman device for left atrial appendage closure (LAAC).
At Stanford Health Care, we work together to find the best way to reduce your risk of stroke. We offer left atrial appendage closure using the Watchman FLX™ and the Amplatzer™ Amulet™. These devices are FDA-approved to lower the risk of AFib-related strokes.
Indication for use (IFU) of the Watchman device is to reduce the risk of stroke or systemic thromboembolism from the left atrial appendage in patients with nonvalvular AF who: Are at increased risk of stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy.
May 11, 2018 · Since its FDA approval in March 2015, the Watchman™ left atrial appendage closure device has been implanted into nearly 50,000 patients with nonvalvular atrial fibrillation (AF) as a nonpharmacologic alternative for reducing stroke risk.
