{"id":619,"date":"2022-11-01T08:31:57","date_gmt":"2022-11-01T15:31:57","guid":{"rendered":"https:\/\/shapememordev.wpenginepowered.com\/japan\/?page_id=619"},"modified":"2025-01-15T10:27:02","modified_gmt":"2025-01-15T18:27:02","slug":"aortic-solutions","status":"publish","type":"page","link":"https:\/\/www.shapemem.com\/japan\/aortic-solutions\/","title":{"rendered":"Aortic Solutions"},"content":{"rendered":"

[vc_row min_height=”550px” 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“:“130“,“padding-bottom“:“30“}}” custom_bg_color=”{“solid“:{“id“:“custom_color“,“color“:““}}” custom_bg_image=”622″][vc_column width=”2\/3″ css_animation=””][vc_heading heading_text=”A Smart Approach:
\nFuture Solutions” heading_wrapper=”h1″ heading_color=”{“solid“:{“id“:“custom_8600810707808710“,“color“:“#4869f4“}}” 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_column][vc_column width=”1\/3″ css_animation=””][vc_image_element image=”1176″ size_type=”fixed” alignment=”center” preloader=”” css_animation=”” size_fixed=”280×397″][\/vc_column][\/vc_row][vc_row 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” custom_bg_color=”{“solid“:{“id“:““,“color“:““}}” custom_bg_image=”622″][vc_column el_design=”{“desktop“:{“padding-top“:“15“,“padding-right“:“15“,“padding-bottom“:“15“,“padding-left“:“15“}}” width=”2\/3″ css_animation=”” custom_bg_color=”{“solid“:{“id“:““,“color“:““}}”][vc_text_element force_color=”yes” css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”]Post-EVAR aneurysm failure to regress remains a significant unmet clinical need<\/b> associated with higher long-term all-cause mortality.<\/p>\n

Shape Memory Medical is committed to evaluating the potential of shape memory polymer to influence AAA sac behavior through various studies.<\/p>\n

AAA-SHAPE Pivotal Trial<\/h4>\n

The AAA-SHAPE Pivotal Trial is a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill Device to improve abdominal aortic aneurysm (AAA) sac behavior with used with elective endovascular aneurysm repair (EVAR).<\/p>\n

The trial will enroll 180 patients with infrarenal AAA across 50 sites in the U.S., Europe, and New Zealand. Study participants will be randomized 2:1; either to EVAR plus sac management with the IMPEDE-FX RapidFill (the treatment arm) or to standard EVAR(the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions, and mortality through five years.[\/vc_text_element][\/vc_column][vc_column width=”1\/3″ css_animation=””][\/vc_column][\/vc_row][vc_row row_width=”” content_placement=”middle” nav_skin=”light” consent_include=”include” equal_height=”true” custom_bg_color=”{“solid“:{“id“:“Light background“,“color“:“#cae2f1“}}” el_design=”{“desktop“:{“margin-bottom“:“40“}}”][vc_column el_design=”{“desktop“:{“padding-top“:“15“,“padding-right“:“15“,“padding-bottom“:“15“,“padding-left“:“15“}}” width=”1\/4″ css_animation=””]