<> 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 CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy; • Are deemed �� 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? Boston Scientific is committed to finding ways to make safe and effective treatments even better—and WATCHMAN is no exception. 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… 136 0 obj 38 0 obj ��H�L��.�ӳ��a��a1���J�����c,��Z��F�};� … 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� ��. 34 0 obj Information for the use only in countries with applicable health authority product registrations. Device: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY: … 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. With almost 20 years of clinical trial and real world experience - including 10 clinical trials - WATCHMAN has a proven safety record. 2 0 obj [30 0 R 29 0 R 28 0 R 27 0 R 26 0 R 25 0 R] Devices and alternatives. 33 0 obj 31 0 obj However, some patients at high thrombo-embolic risk cannot be treated with oral anticoagulants (OACs) due to major contraindications or intolerance. A-fib prevents the heart from pumping blood correctly. 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. <>]/P 92 0 R/Pg 1 0 R/S/Link>> J Am Coll Cardiol 2013; 61:2551. Rx only. Acrobat PDFMaker 10.1 for Word endobj endobj * Procedure success defined as successful delivery and release of a WATCHMAN FLX device into the LAA 2015-11-13T11:57:14.98Z Be sure to look at the supplements to get an up-to-date information on device changes. A rst-of-its-kind, proven alternative to long-term warfarin therapy for stroke risk reduction in patients with non-valvular atrial brillation. 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. 133 0 obj How Boston Scientific is Responding to the COVID-19 Pandemic >. This would typically require cardiac surgery to retrieve the device. 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. <>]/P 65 0 R/Pg 137 0 R/S/Link>> This would typically require cardiac surgery to retrieve the device. 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. <>]/P 51 0 R/Pg 1 0 R/S/Link>> 41 0 obj It is the therapy of choice for thromboembolism prevention in AF and has proven to be effective for treating DAT. WARNINGS endobj Vascular access anatomy (e.g., femoral vein size, thrombus, or tortuosity). 1 0 obj Use caution when introducing a WATCHMAN Access System to prevent damage to cardiac structures. endobj You may be seeing the ads for a device called Watchman. 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 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; endobj This device has not been studied in pregnant or breastfeeding women. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. 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. application/pdf Contents QuantityDescription 1 WATCHMAN Access System INTENDED USE/ INDICATIONS FOR USE The WATCHMAN Access System is intended to provide vascular Badger2021 • • 17 Replies. 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