{"id":2106,"date":"2026-03-26T09:48:24","date_gmt":"2026-03-26T16:48:24","guid":{"rendered":"https:\/\/shapememordev.wpenginepowered.com\/japan\/?page_id=2106"},"modified":"2026-03-26T12:33:45","modified_gmt":"2026-03-26T19:33:45","slug":"flagship","status":"publish","type":"page","link":"https:\/\/www.shapemem.com\/japan\/flagship\/","title":{"rendered":"FLAGSHIP"},"content":{"rendered":"

[vc_row 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=”{“tablet_portrait“:{“padding-top“:“100“,“padding-bottom“:“30“},“desktop“:{“padding-top“:“180“,“padding-bottom“:“50“}}” custom_bg_color=”{“solid“:{“id“:“Main accent color“,“color“:“#2a327e“}}” custom_bg_image=”672″][vc_column css_animation=””][vc_heading heading_text=”FLAGSHIP Early Feasibility Trial” heading_wrapper=”h1″ heading_color=”{“solid“:{“id“:“Main accent color“,“color“:“#2a327e“}}” 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_text_element css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”]Investigational device, limited by Federal (or United States) law to investigational use.[\/vc_text_element][\/vc_column][\/vc_row][vc_section nav_skin=”light”][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“:“30“,“padding-bottom“:“30“}}” custom_bg_color=”{“solid“:{“id“:“custom_color“,“color“:““}}” custom_bg_image=”622″][vc_column width=”3\/5″ css_animation=””][vc_text_element force_color=”yes” css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”]The aorta, your largest artery, is the main pathway which carries blood from your heart to the rest of your body.\u00a0 Various disorders and conditions that affect the aorta are classified as aortic diseases.<\/p>\n

Aortic dissection is a serious condition in which there is a separation between the inner and middle layers of the aorta. When blood flows through that separation (dissection), a new flow channel is created, also referred to as a \u201cfalse lumen\u201d. This can be a life-threatening situation.<\/p>\n

Aortic dissections can be treated through open surgical repair, or through an endovascular (less invasive), life-saving procedure called TEVAR (Thoracic Endovascular Aortic Repair).<\/p>\n

However, TEVAR alone for aortic dissection does not always address the abnormal false lumen flow. This unmet clinical need is significant and can be associated with higher risks of complications, rehospitalization, increased costs, and increased mortality.<\/p>\n

Shape Memory Medical is dedicated to patients and physicians by developing new aortic restorative therapies using our novel smart polymer technology through various clinical studies.[\/vc_text_element][\/vc_column][vc_column width=”2\/5″ css_animation=””][vc_image_element image=”2111″ alignment=”center” preloader=”” css_animation=”” max_width=”418″][\/vc_column][\/vc_row][\/vc_section][vc_row content_placement=”middle” nav_skin=”light” consent_include=”include” equal_height=”true” custom_bg_color=”{“solid“:{“id“:““,“color“:““}}”][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 css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”]<\/p>\n

FLAGSHIP First in Human Study<\/h4>\n

FLAGSHIP FIH is the first prospective clinical trial to evaluate the Smart False Lumen Device in Aortic Dissection patients and its potential to remodel the flow and occlude the tear using various approaches. The study will enroll up to 30 patients across two centers in New Zealand.[\/vc_text_element][\/vc_column][vc_column width=”1\/3″ css_animation=””][\/vc_column][\/vc_row][vc_section nav_skin=”light”][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“:“20“}}”][vc_column el_design=”{“desktop“:{“padding-top“:“15“,“padding-right“:“15“,“padding-bottom“:“15“,“padding-left“:“15“}}” width=”1\/4″ css_animation=””]