37 0 obj 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: Implantation of the WATCHMAN FLX Device should only be performed by interventional cardiologists and/ or electrophysiologists who are trained in percutaneous and transseptal procedures and who have completed the WATCHMAN FLX Physician Training program. 2015-11-13T12:01:46.71Z Be sure to look at the supplements to get an up-to-date information on device changes. 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. For the Watchman device, this includes OACs for 6 weeks, dual antiplatelet therapy for 6 months, and aspirin for life according to the PROTECT AF trial protocol. endobj Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. uuid:609cd6cb-25e5-4cda-9bb9-311d4403c3ff Rx only. ��H�L��.�ӳ��a��a1���J�����c,��Z��F�};� 44 0 obj Device: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE … However, some patients at high thrombo-embolic risk cannot be treated with oral anticoagulants (OACs) due to major contraindications or intolerance. 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… 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. 13 Furthermore, several noninferiority trials of new devices compared with Watchman are ongoing or planned. Another problem: advocates for the device have used selective reporting and publishing of trial results to alter the way patients and doctors perceive reality. Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safet… 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. Use caution when introducing a WATCHMAN Access System to prevent damage to cardiac structures. Devices and alternatives. 2015-11-13T11:52:14Z In considering the use of the WATCHMAN FLX Device, the rationale for seeking an alternative to long-term anticoagulation therapy and the safety and effectiveness of the device compared to anticoagulation should be taken into account. 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. 2. Contents QuantityDescription 1 WATCHMAN Access System INTENDED USE/ INDICATIONS FOR USE The WATCHMAN Access System is intended to provide vascular 49 0 obj * Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA. Allergic reaction to the contrast media, anesthetic, WATCHMAN Implant material, or medications, Bruising, hematoma, or seroma near the catheter insertion site, Inability to reposition, recapture, or retrieve the device, Misplacement of the device/improper seal of the appendage/movement of device from appendage wall, TEE complications (e.g., throat pain, bleeding, esophageal trauma), Contact a Boston Scientific Representative. <>]/P 65 0 R/Pg 137 0 R/S/Link>> The WATCHMAN™ Device is permanently implanted at or slightly distal to the ostium (opening) of the LAA, which is known to be the source of more than 90% of stroke-causing bloods clots in people with non-valvular AF. endobj Following the encouraging news from irina1975, I have been looking in to Watchman for myself. Have an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy. 1 0 obj Like this one> The appendage-closure idea was a good one: during atrial fibrillation (AF), blood can pool in the left atrial appendage, and this promotes clot formation. <> <> 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… endobj ecb34eac9b87851d86489ef58db9774a6f040ee8 Ninety per cent of thrombi leading to stroke in patients with atrial fibrillation (AF) are formed in the left atrial appendage (LAA).1,2Warfarin and new oral anticoagulants (NOACs) reduce significantly the thrombo-embolic risk associated with AF. Watchman indications. With all medical procedures there are risks associated with the implant procedure and the use of the device. An LAAO device may be considered for stroke prevention in patients with AF with contra-indications to long-term anticoagulation (Class IIb, LOE B).2 The most widely used catheter-based devices are the Watchman (Boston Scientific, MA, USA) and AMULET (St. Jude Medical, MN, USA). endobj Although registries provide less information than randomized controlled trials regarding indications and net clinical benefit, ... but in the Belgian registry no differences were observed between the Watchman device or AMPLATZER cardiac plug/Amulet devices. endobj Of note: Factors that need to be considered for the WATCHMAN FLX Device and implantation procedure include the following: Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to: There may be other potential adverse events that are unforeseen at this time. While effective in preventing many embolic strokes, it also negates endocrine contribution of the LAA. Information for the use only in countries with applicable health authority product registrations. <>]/P 65 0 R/Pg 137 0 R/S/Link>> 136 0 obj <> 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 … 15 0 obj 2015-11-13T11:52:16Z Are deemed by their physicians to be suitable for warfarin; and 3. <>]/P 91 0 R/Pg 1 0 R/S/Link>> Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. A-fib prevents the heart from pumping blood correctly. 12 In the majority of cases when the ACP/Amulet is adequately implanted, post-procedural DAPT therapy … 2 The most widely used catheter-based devices are the Watchman (Boston Scientific, MA, USA) and AMULET (St. Jude Medical, MN, USA). Blood clots may form in the pooled blood. <>]/P 51 0 R/Pg 1 0 R/S/Link>> The implantation of thrombogenic devices in patients with nonvalvular AF who are at high risk of thrombosis in the left atrium requires antithrombotic therapy to prevent on-device thrombus formation ().Ideally, antithrombotic therapy should be pursued until complete occluder endothelialization occurs. In order to reduce the risk for stroke in these patients, endovascular LAA occlusion (LAAO) using the percutaneous appro… 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. Device Embolization – The Watchman Device, if not seated properly, could theoretically come loose and essentially float freely until it became trapped in a heart structure. H��WKs�8��W�HU��7���ʎ��lMv2e��́��dlq���^�$g��� � �ht���՛���Q�_~Y�{��Z���_��_�ŗE�D��de���*��J�yU�Q->����q�ۧ����Ub��u]eq-�J��(�4*�X��=,Vobq�/�\�~����Z/V����O���\�n�Z�Y��A����꿉MRG��DgQ]����E3n���yPb��jZ�(Vkz{���u�����V�n��=���i�-V�u,�XZ�D�x���I�X?,�\��=}}�ϫ�p���8��\�e�ٲ������}������Ьג]����˨Lȿ���A�U ��"q���rA.�Z�g� ��8��积��g��� ͳL.e��_�.b\��-$�� ./ſ�I��2��,�,��G�ONk먨Sv~>�M��a����K���xi�A3�� �&�&����ˤ��f��$)����'���,��j��H� H`] 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. endobj How Boston Scientific is Responding to the COVID-19 Pandemic >. Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy; 2. Results Presented at HRS 2020. Acrobat PDFMaker 10.1 for Word The device is meant to be an option for high-risk patients seeking an alternative to warfarin. ©2021 Boston Scientific Corporation or its affiliates. 189 0 obj If using a power injector, the maximum pressure should not exceed 100 psi. It is designed to seal off the heart’s left atrial appendage (LAA), a sack-like pouch within one of the organ’s two upper chamber. ** Occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention. 47 0 obj endobj endobj … <>]/P 91 0 R/Pg 1 0 R/S/Link>> Be sure to look at the supplements to get an up-to-date information on device changes. 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