{"id":1462,"date":"2023-08-25T13:03:56","date_gmt":"2023-08-25T20:03:56","guid":{"rendered":"https:\/\/shapememordev.wpenginepowered.com\/japan\/?page_id=1462"},"modified":"2026-04-02T12:16:42","modified_gmt":"2026-04-02T19:16:42","slug":"aaa-shape-ide","status":"publish","type":"page","link":"https:\/\/www.shapemem.com\/japan\/aaa-shape-ide\/","title":{"rendered":"AAA-SHAPE IDE"},"content":{"rendered":"

[vc_row row_height_type=”fixed_height_screen” height=”60″ min_height=”275px” content_placement=”middle” custom_bg_type=”image” custom_bg_cover=”cover” custom_bg_repeat=”no-repeat” custom_bg_position=”Center center” nav_skin=”light” consent_include=”include” equal_height=”true” el_design=”{“desktop“:{“padding-top“:“200“,“padding-bottom“:“160“}}” custom_bg_color=”{“solid“:{“id“:“Main accent color“,“color“:“#2a327e“}}” custom_bg_image=”676″][vc_column css_animation=””][vc_heading heading_text=”AAA-SHAPE Pivotal Trial” heading_wrapper=”h1″ heading_color=”{“solid“:{“id“:“Light text color“,“color“:“#ffffff“}}” heading_typography=”{“font_family“:“240743169“,“font_size“:“60px“,“line_height“:“1.2em“,“letter_spacing“:“-0.03em“}” responsiveness=”yes” tablet_portrait=”90″ mobile_landscape=”80″ mobile_portrait=”70″ css_animation=””][vc_empty_space height=”60px”][vc_row_inner consent_include=”include” el_design=”{“desktop“:{“margin-bottom“:“10“}}”][vc_column_inner width=”1\/4″ css_animation=””][vc_button_custom title=”INSTRUCTIONS FOR USE” text_typography=”{“font_size“:“12px“}” size=”2″ display=”display_block” button_align=”btn_align_left” css_animation=”” text_color=”{“id“:“Main accent color“,“color“:“#2a327e“}” bg_color=”{“solid“:{“id“:“Light background“,“color“:“#cae2f1“}}” border_radius=”{“top-left“:20,“top-right“:20,“bottom-right“:20,“bottom-left“:20,“property“:“border“,“suffix“:“radius“}” bg_color_h=”{“solid“:{“id“:“Light text color“,“color“:“#ffffff“}}” el_class=”buttonwrap” link=”url:https%3A%2F%2Fwww.shapemem.com%2Fwp-content%2Fuploads%2F2026%2F03%2FIFU1434-Rev-01-Artwork_Instructions-For-Use-IMPEDE-FX-RapidFill-Aortic-pdf.pdf|title:IFU1434|target:_blank”][\/vc_column_inner][vc_column_inner width=”1\/4″ css_animation=””][vc_button_custom title=”AAA-SHAPE Patient Booklet” text_typography=”{“font_size“:“12px“}” size=”2″ display=”display_block” button_align=”btn_align_left” css_animation=”” text_color=”{“id“:“Main accent color“,“color“:“#2a327e“}” bg_color=”{“solid“:{“id“:“Light background“,“color“:“#cae2f1“}}” border_radius=”{“top-left“:20,“top-right“:20,“bottom-right“:20,“bottom-left“:20,“property“:“border“,“suffix“:“radius“}” bg_color_h=”{“solid“:{“id“:“Light text color“,“color“:“#ffffff“}}” el_class=”buttonwrap” link=”url:https%3A%2F%2Fwww.shapemem.com%2Fwp-content%2Fuploads%2F2026%2F03%2FCRD1031-Rev-A-AAA-SHAPE-Flip-Book.pdf|title:CRD1031%20Rev%20A|target:_blank”][\/vc_column_inner][vc_column_inner width=”1\/4″ css_animation=””][\/vc_column_inner][vc_column_inner width=”1\/4″ css_animation=””][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_section nav_skin=”light”][vc_row nav_skin=”light” consent_include=”include”][vc_column el_design=”{“desktop“:{“padding-top“:“15“,“padding-right“:“15“,“padding-bottom“:“40“,“padding-left“:“15“}}” css_animation=””][vc_text_element force_color=”yes” css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”]<\/p>\n

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IMPEDE-FX RapidFill\u00ae<\/sup><\/span><\/h3>\n<\/div>\n<\/div>\n
\n
\n

Caution \u2013 INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.<\/strong><\/p>\n

Intended Use and Indication for Use: <\/strong>The IMPEDE-FX RapidFill Device is intended to be used with commercially available endovascular grafts in the treatment of patients meeting the minimum anatomical criteria, with infrarenal abdominal aortic aneurysms (AAAs). Once the endovascular aneurysm repair (EVAR) procedure is complete, the IMPEDE-FX RapidFill Device is used to fill the aneurysm sac with IMPEDE-FX RapidFill implants to promote aneurysm shrinkage.<\/p>\n<\/div>\n<\/div>\n

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MRI & Safety Information<\/h3>\n<\/div>\n<\/div>\n
\n
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MR CONDITIONAL<\/u><\/strong><\/p>\n

Non-clinical testing and MRI simulations demonstrated that the IMPEDE-FX RapidFill is MR Conditional. Refer to Table 1<\/strong> for the MRI Safety Information.<\/strong><\/p>\n<\/div>\n<\/div>\n

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