watchman device indications


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; Rx only. <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 1/Type/Page>> A-fib prevents the heart from pumping blood correctly. 189 0 obj Devices and alternatives. endobj In the Watchman trials, the risk of stroke after receiving a Watchman device is overall similar, or non-inferior in clinical trial terms, when it was compared to warfarin for stroke risk reduction. <> DEVICE DESCRIPTION The WATCHMAN Access System (Access Sheath and Dilator) is compatible with components of all WATCHMAN Left Atrial Appendage Closure Devices. endobj Use caution when accessing the LAA, and deploying, recapturing, and repositioning the Closure Device. While effective in preventing many embolic strokes, it also negates endocrine contribution of the LAA. %PDF-1.5 %���� * Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA. The implant is designed to prevent blood clots caused by atrial fibrillation (A-fib) from getting into the bloodstream. <> 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. The presence of indication(s) for long-term anticoagulation therapy, other than non-valvular atrial fibrillation (e.g. <>]/P 51 0 R/Pg 1 0 R/S/Link>> 2015-11-13T11:52:16Z 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. This device has been shown to non-inferior to anti coagulation therapy in reducing the risk of stroke. 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 … endobj endobj <>]/P 65 0 R/Pg 137 0 R/S/Link>> uuid:f59374c2-e311-44d1-8fa9-4f944a771268 Though this device is yet to be formally approved for a clinical indication in the USA, the WATCHMAN appendage occlusion device remains the most rigorously examined and studied of all transcatheter-based devices in this space. [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] endobj Do not release (i.e., unscrew) the WATCHMAN FLX Device from the core wire unless all release criteria are satisfied to avoid suboptimal results. 2015-11-13T11:52:16Z Ability of the patient to undergo required imaging. The safety and effectiveness (and benefit-risk profile) of the WATCHMAN FLX Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated. The risk of stroke does not become zero, but it is equivalent to being on a blood thinner but without the major bleeding risks. It consists of a semi-spherical nitinol frame with a polyethylene terephthalate membrane coating to block thrombus embolization and 10 fixation barbs that anchor the device into the LAA. Another problem: advocates for the device have used selective reporting and publishing of trial results to alter the way patients and doctors perceive reality. Information for the use only in countries with applicable health authority product registrations. Though this device is yet to be formally approved for a clinical indication in the USA, the WATCHMAN appendage occlusion device remains the most rigorously examined and studied of all transcatheter-based devices in this space. It is used to cut off the left auricle from the blood flowing through the heart hence preventing it from releasing clots that might cause stroke. Strategy Occlusion of the left atrial appendage can be achieved from an outside perspective (the #Lariat device) or an inside (endovascular) blood exposed device (#Watchman first in this endeavor). 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. endobj 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. The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke. INDICATIONS FOR USE The WATCHMAN™ Device is indicated to reduce the risk of thromboembolism from the LAA in patients with non-valvular atrial fibrillation who: Are at an increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy, Are deemed to be suitable for short-term (at least 45 days), but not long-term, …

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