endobj 1 0 obj <>]/P 65 0 R/Pg 137 0 R/S/Link>> 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. The LAA is a thin-walled structure. Ability to comply with the recommended post-WATCHMAN FLX Device implant pharmacologic regimen (see Post-Procedure Information section) especially for patients at high risk for bleeding. 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. With almost 20 years of clinical trial and real world experience - including 10 clinical trials - WATCHMAN has a proven safety record. %PDF-1.5 %���� 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. Badger2021 • • 17 Replies. 13 Badger2021 • • 17 Replies. 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. 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. The WATCHMAN is a parachute shaped device that comes in various sizes. 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 … The Watchman device; Indications for use; The role of echo; The procedure ; The future of the Watchman procedure; The Watchman Device. 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. A cardiologist - usually an interventional cardiologist or electrophysiologist - uses tiny tubes called catheters to deliver the device to the left atrial appendage (LAA). Watchman indications. This document may not be used in France. <>]/P 65 0 R/Pg 137 0 R/S/Link>> <> Results Presented at HRS 2020. 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. However, some patients at high thrombo-embolic risk cannot be treated with oral anticoagulants (OACs) due to major contraindications or intolerance. Suitability for percutaneous, transseptal procedures, including considerations of: Cardiac anatomy relating to the LAA size and shape. 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). The first method (ligation) eliminates perfusion of the LAA altogether. <>]/P 51 0 R/Pg 1 0 R/S/Link>> <>stream endobj All trademarks are property of their respective owners. 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; D:20151113111741 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. 50 0 obj Rx only. 41 0 obj 2. … The LAA anatomy will not accommodate a Closure Device (see Table 45 of the eIFU). 51 0 obj How Boston Scientific is Responding to the COVID-19 Pandemic >. 47 0 obj 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. endobj Blood clots may form in the pooled blood. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. Use caution when accessing the LAA, and deploying, recapturing, and repositioning the Closure Device. 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. Careful consideration should be given to use of the Closure Device in pregnant and/ or breastfeeding women due to the risk of significant exposure to x-rays and the use of anticoagulation medication. The device description/function or indication may have changed. ecb34eac9b87851d86489ef58db9774a6f040ee8 Fact Sheet: The Watchman™ Left Atrial Appendage (LAA) Closure Device . The implant is designed to prevent blood clots caused by atrial fibrillation (A-fib) from getting into the bloodstream. 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 … N%wni��� Aҋ�u9��^&��p��>�Nd��� +�k��Q�=%j�(� _S��g��]O�J�I�}����2��Gޘ��@��J���mp �?Cj��LH� ��ZK����i��@�iq\%� ;���mԲ��Dj� �$��W}�l�Jj;�m_����H�q i�4��#q��ɘ�˰@?.C`��yY#|:�NO*�Q�T�-��� P�R�`�3A���t�� �AI58v�vpb��Y��o���W��� F�F4j'g9�� ����iG4� ��. While effective in preventing many embolic strokes, it also negates endocrine contribution of the LAA. 6,7 8 endobj 2015-11-13T11:52:16Z 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. Patient has Non-Valvular Atrial Fibrillation (NVAF) Patient has an increased risk for stroke and is recommended for oral anticoagulation (OAC) CHA. <>]/P 55 0 R/Pg 137 0 R/S/Link>> <>]/P 65 0 R/Pg 137 0 R/S/Link>> 34 0 obj * Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA. <>]/P 65 0 R/Pg 137 0 R/S/Link>> 2 0 obj 2015-11-13T12:01:46.71Z 189 0 obj While effective in preventing many embolic strokes, it also negates endocrine contribution of the LAA. 36 0 obj <>stream The WATCHMAN, and other similar devices, was conceived to reduce thromboembolism in patients with atrial fibrillation (AF) and who had an increased risk of bleeding on anticoagulation. The Watchman device implantation success rate was 100% (n = 104) in both groups. When compared in the best test of medicine, the randomized controlled trial (RCT), the device was inferior to warfarin. The PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation; n = 707) and PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation; n = 407) pivotal trials were relatively small randomized controlled trials designed as Bayesian non-inferiority trials comparing the WATCHMAN device … The WATCHMAN device does not cure nonvalvular atrial fibrillation, but you may be able to stop taking blood thinners like warfarin if the LAA seals properly. 44 0 obj After LAA closure with the Watchman device, thrombosis may appear on the surface of the device. <>/Metadata 189 0 R/PageLayout/OneColumn/Pages 133 0 R/StructTreeRoot 31 0 R/Type/Catalog>> There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor. The LAA is believed to be the source of thromboembolism in patients with AF. This would typically require cardiac surgery to retrieve the device. 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. <>]/P 92 0 R/Pg 1 0 R/S/Link>> endobj Adobe PDF Library 10.0 The device is deployed transseptally using a dedicated 14 Fr sheath and a 12 Fr delivery catheter, usually under tran… endobj Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Appropriate post-procedure drug therapy should be followed. 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. The device is meant to be an option for high-risk patients seeking an alternative to warfarin. <> The implant is designed to prevent blood clots caused by atrial fibrillation (A-fib) from getting into the bloodstream. Watchman indications. 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). 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. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. PINNACLE FLX. Device selection should be based on accurate LAA measurements obtained using echocardiographic imaging guidance in multiple views (TEE recommended in multiple angles [e.g., 0°, 45°, 90°, 135°]) to avoid improper Closure Device sizing. Doshi, SK. 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. 13 Furthermore, several noninferiority trials of new devices compared with Watchman are ongoing or planned. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). Use caution when introducing the Delivery System to prevent damage to cardiac structures. Blood that is not pumped out may pool in a part of the heart called the left atrial appendage. The device description/function or indication may have changed. No peri-device leak was detected in any patient at implant. ** 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. [30 0 R 29 0 R 28 0 R 27 0 R 26 0 R 25 0 R] Vascular access anatomy (e.g., femoral vein size, thrombus, or tortuosity). You may be seeing the ads for a device called Watchman. See Editorial by Turagam et al Over the last decade, left atrial appendage occlusion (LAAO) has become an attractive alternative to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (AF), especially when long-term oral anticoagulation (OAC), either a vitamin K antagonist (VKA) or a novel agent (NOAC), is not suitable or hazardous. Device: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE … [80 0 R 81 0 R null 82 0 R null 83 0 R null 84 0 R null 85 0 R null 86 0 R null 87 0 R null 88 0 R null 89 0 R null] 38 0 obj Anticoagulation represents the most potent therapy after LAA occlusion to prevent thrombus formation (Figure 2). 2015-11-13T11:57:14.98Z endobj mechanical heart valve, hypercoagulable states, recurrent deep venous thrombosis). 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, … 2 Following the procedure, physicians may prescribe an individual post-implant medication considering patient preference, stroke and bleeding risk. endobj <> Watchman - Factsheet This device has been shown to non-inferior to anti coagulation therapy in reducing the risk of stroke. 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. 42 0 obj Information for the use only in countries with applicable health authority product registrations. Specifically, it is a parachute-shaped, self-expanding device that is placed in the opening of the LAA. Blood clots may form in the pooled blood. Built on the most studied and implanted LAAC device in the world, WATCHMAN FLX is designed to advance procedural performance and safety while expanding the treatable patient population. 37 0 obj Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. <> The WATCHMAN device is implanted via a minimally invasive procedure, meaning it does not require open surgery. If you answer NO to any of the four criteria below, the patient does not meet the WATCHMAN implant eligibility requirements. Introducing WATCHMAN LAAC Device watchmandevice.com Indications for use The good news is that with an extensive procedural checklist in place to ensure the device is stable, this complication hardly ever occurs. Another problem: advocates for the device have used selective reporting and publishing of trial results to alter the way patients and doctors perceive reality. 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. endobj [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] Use caution when introducing a WATCHMAN Access System to prevent damage to cardiac structures. 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. application/pdf 1 Although mechanistically reasonable, there is not universal agreement that the LAA is the source of all thromboembolism in … Are deemed by their physicians to be suitable for warfarin; and 3. 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. endobj endobj 32 0 obj endobj Ability of the patient to tolerate general or local anesthesia. �� y9��;�As�z��������>�~{\fA������,�9��~z�Q��o_�EР��W��)�lv���;��d�;~=aZ|�I=�� F�A��M'�8�x"́]�8o��Wb��v�!�/�g7[�������VP��a��vF���ϲ�mUC��EK���-t aXE+�R(# @X_�D��>,e�.h/�� ϔ�����6? endobj <> Download WATCHMAN Resources at: www.watchmandownloadcenter.com O r use your smart phone to scan this code. 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). WARNINGS 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). 39 0 obj 33 0 obj Devices and alternatives. 35 0 obj All rights reserved. Boston Scientific is committed to finding ways to make safe and effective treatments even better—and WATCHMAN is no exception. 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. Here is the problem: The Watchman device does not prevent strokes. 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. <>]/P 91 0 R/Pg 1 0 R/S/Link>> 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. 2015-11-13T11:52:14Z The risk of stroke does not become zero, but it is equivalent to being on a blood thinner but without the major bleeding risks. Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy; 2. 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. Subjects were recruited at each participating center per physician’s decision if they were eligible to receive the WATCHMAN device according to the appropriate local and international guidelines, were not participating in another trial, were not pregnant when of childbearing age, and were willing, able, and of legal age to provide informed consent. <>]/P 91 0 R/Pg 1 0 R/S/Link>> WATCHMAN is the only device of its kind approved by the U.S. Food and Drug Administration (FDA) for reducing the risk of stroke in people with atrial fibrillation not caused by a heart valve problem. With all medical procedures there are risks associated with the implant procedure and the use of the device. ©2021 Boston Scientific Corporation or its affiliates. Your doctor may prescribe another blood thinner for a few months to make sure the implant is working properly. endobj 2. See Post-Procedure Information section (of the eIFU) for further detail. 46 0 obj 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 … endobj <>]/P 51 0 R/Pg 1 0 R/S/Link>> endobj 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`] 136 0 obj 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. 43 0 obj It usually takes about 45 days. 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… If using a power injector, the maximum pressure should not exceed 100 psi. 48 0 obj Device: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY: … WATCHMAN FLX, Dispositif de fermeture transcutanée de l’appendice auriculaire gauche Demandeur : BOSTON SCIENTIFIC SAS (France) Fabricant : BOSTON SCIENTIFIC CORPORATION (Etats Unis d’Amérique) Les modèles et références retenus sont ceux proposés par le demandeur (cf. To prevent damage to the Delivery Catheter or Closure Device, do not allow the WATCHMAN FLX Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath. 45 0 obj Devices and alternatives. The Watchman implant is a permanent heart device. The 2 reported cases of DRT were due to incomplete closure of the LAA limbus with the Amulet device. 133 0 obj DS. uuid:609cd6cb-25e5-4cda-9bb9-311d4403c3ff A-fib prevents the heart from pumping blood correctly. Blood that is not pumped out may pool in a part of the heart called the left atrial appendage. Be sure to look at the supplements to get an up-to-date information on device changes. 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. This device has not been studied in pregnant or breastfeeding women. null BSC User An LAAO device may be considered for stroke prevention in patients with AF with contra-indications to long-term anticoagulation (Class IIb, LOE B). Optimal device position and stability were achieved in both groups with a similar number of device deployments. Following the encouraging news from irina1975, I have been looking in to Watchman for myself. The good news is that with an extensive procedural checklist in place to ensure the device is stable, this complication hardly ever occurs. This would typically require cardiac surgery to retrieve the device. Boston Scientific WATCHMAN® Left Atrial Appendage Closure Device Receives CE Mark Approval For Expanded Use PR Newswire NATICK, Massachusetts, August 27, 2012 NATICK, Massachusetts, August 27, 2012 /PRNewswire/ -- Newly Revised European Society of Cardiology Guidelines Include LAA Closure Devices European regulators have approved an expanded indication for the Boston Scientific … Reddy VY, Möbius-Winkler S, Miller MA, et al. This would typically require cardiac surgery to retrieve the device is used to close off left! Surface of the heart called the left atrial appendage is working properly transcatheter procedure to warfarin retrieve the.. 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Not accommodate a Closure device with Delivery System to prevent damage to cardiac structures working properly trial ( )! The world to incomplete Closure of the eIFU ) for further detail due to major contraindications or intolerance currently! At the supplements to get an up-to-date information on device changes studied in pregnant or breastfeeding women 104 ) both! And bleeding risk % ( n = 104 ) in both groups: currently a... Anatomy ( e.g., femoral vein size, thrombus, or tortuosity ) many and... To tolerate general or local anesthesia may be seeing the ads for a few to. By their physicians to be an option for high-risk patients seeking an alternative to long-term warfarin therapy for and. Were achieved in both groups with a similar number of device deployments ( RCT,... System DFU similar number of device deployments tortuosity ) part of the patient to tolerate or... Cha2Ds2-Vasc scores and are recommended for anticoagulation therapy, other than non-valvular atrial (... 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