Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy; Are deemed by their physicians to be suitable for anticoagulation therapy; and. 133 0 obj INTENDED USE/ INDICATIONS FOR USE The WATCHMAN Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. endobj endobj <>]/P 91 0 R/Pg 1 0 R/S/Link>> 42 0 obj Watchman indications. Patient has Non-Valvular Atrial Fibrillation (NVAF) Patient has an increased risk for stroke and is recommended for oral anticoagulation (OAC) CHA. <> 39 0 obj BSC User The good news is that with an extensive procedural checklist in place to ensure the device is stable, this complication hardly ever occurs. While effective in preventing many embolic strokes, it also negates endocrine contribution of the LAA. Indications for Use The WATCHMAN™ Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: –Are at increased risk for stroke and systemic embolism based on CHADS 2 or CHA 2 DS 2-VASc scores and are recommended for anticoagulation therapy; –Are deemed by their physicians to be suitable for … uuid:f59374c2-e311-44d1-8fa9-4f944a771268 43 0 obj 36 0 obj However, some patients at high thrombo-embolic risk cannot be treated with oral anticoagulants (OACs) due to major contraindications or intolerance. The EP Wire survey has revealed that the most common indications for LAAO are stroke prevention in patients at high thrombo-embolic risk and absolute contraindications to oral anticoagulation (OAC) therapy or a history of bleeding. <>]/P 51 0 R/Pg 1 0 R/S/Link>> 13 Furthermore, several noninferiority trials of new devices compared with Watchman are ongoing or planned. endobj The WATCHMAN Left Atrial Appendage Closure Device with Delivery System (WATCHMAN device) and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (WATCHMAN FLX device… WARNINGS CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. endobj The WATCHMAN FLX Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy; This device has been shown to non-inferior to anti coagulation therapy in reducing the risk of stroke. See Post-Procedure Information section (of the eIFU) for further detail. In the largest randomized controlled trials comparing either LAA closure with the Watchman device or warfarin therapy in patients eligible for long-term OAT (the PROTECT AF and PREVAIL studies3,4), it was recommended to give aspirin (81–325 mg) indefinitely with warfarin for 45 … The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: 1. 37 0 obj Results Presented at HRS 2020. endobj endobj The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. CONTRAINDICATIONS Refer to WATCHMAN Left Atrial Appendage Closure Device with Delivery System DFU. endobj Blood clots may form in the pooled blood. <>]/P 92 0 R/Pg 1 0 R/S/Link>> [120 0 R 121 0 R 122 0 R 123 0 R 124 0 R null null 65 0 R null null null 75 0 R null null null 74 0 R null null null 73 0 R null null null 72 0 R null null 125 0 R 126 0 R null null 127 0 R null null 128 0 R null null 55 0 R null null null 63 0 R null null null 62 0 R null null null 61 0 R null null null 129 0 R null 41 0 R 65 0 R 42 0 R 65 0 R 43 0 R 65 0 R 44 0 R 65 0 R 45 0 R 65 0 R 46 0 R 55 0 R] <> 2015-11-13T11:52:16Z The WATCHMAN Device (Boston Scientific; Natick, MA) is the most extensively studied and the only Food and Drug Administration (FDA) approved percutaneous LAA closure device available in the United States. An LAAO device may be considered for stroke prevention in patients with AF with contra-indications to long-term anticoagulation (Class IIb, LOE B). This would typically require cardiac surgery to retrieve the device. uuid:609cd6cb-25e5-4cda-9bb9-311d4403c3ff 33 0 obj Details regarding the indications, contraindications, warnings, and precautions for oral anticoagulants approved for patients with non-valvular atrial fibrillation are provided in their respective Instructions for Use. Use caution when accessing the LAA, and deploying, recapturing, and repositioning the Closure Device. The recent meta-analysis of the final 5-year outcome data of the randomized controlled trials PROTECT-AF (Percutaneous Closure of the Left Atrial Appendage Ver… DEVICE DESCRIPTION The WATCHMAN Access System (Access Sheath and Dilator) is compatible with components of all WATCHMAN Left Atrial Appendage Closure Devices. With all medical procedures there are risks associated with the implant procedure and the use of the device. The Watchman LAA Closure Device is indicated as a treatment alternative to patients with AF, either indicated or contraindicated to anticoagulation therapy, thus extending the benefits of the therapy to a wider population and especially to those at higher risk than others. There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor. 136 0 obj <>]/P 65 0 R/Pg 137 0 R/S/Link>> endobj Vascular access anatomy (e.g., femoral vein size, thrombus, or tortuosity). 18 A systematic review of 30 published studies on DRT reported a cumulative incidence of 3.9% (WATCHMAN 3.4%, ACP 4.8%, and Amulet 2.0%) from 2,118 LAA closure devices. It usually takes about 45 days. 2. Watchman indications. All trademarks are property of their respective owners. The first method ( ligation ) eliminates perfusion of the heart called the left atrial appendage ) for long-term therapy! 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