{"id":1770,"date":"2024-10-08T11:51:45","date_gmt":"2024-10-08T18:51:45","guid":{"rendered":"https:\/\/shapememordev.wpenginepowered.com\/japan\/?page_id=1770"},"modified":"2026-04-02T12:14:00","modified_gmt":"2026-04-02T19:14:00","slug":"fle","status":"publish","type":"page","link":"https:\/\/www.shapemem.com\/japan\/fle\/","title":{"rendered":"False Lumen Embolization System"},"content":{"rendered":"

[vc_row row_height_type=”fixed_height_screen” height=”50″ 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=”False Lumen Embolization System” 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=”PATIENT IMPLANT INFORMATION” text_typography=”{“font_size“:“12px“}” size=”2″ display=”display_block” button_align=”btn_align_left” css_animation=”” link=”url:https%3A%2F%2Fwww.shapemem.com%2Fwp-content%2Fuploads%2F2026%2F03%2FLBL1415-01-Rev-01-Patient-Implant-Information-False-Lumen_EN-FR.pdf|target:_blank” text_color=”{“id“:“Main accent color“,“color“:“#2a327e“}” bg_color=”{“solid“:{“id“:“Light background“,“color“:“#cae2f1“}}” text_color_h=”{“id“:“Main accent color“,“color“:“#2a327e“}” bg_color_h=”{“solid“:{“id“:“Light text color“,“color“:“#ffffff“}}” el_class=”buttonwrap” border_radius=”{“top-left“:20,“top-right“:20,“bottom-right“:20,“bottom-left“:20,“property“:“border“,“suffix“:“radius“}”][\/vc_column_inner][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=”” link=”url:https%3A%2F%2Fwww.shapemem.com%2Fwp-content%2Fuploads%2F2026%2F03%2FIFU1408-Rev-05-Artwork_Instructions-for-Use-False-Lumen-Embolization-System.pdf|target:_blank” 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“}” text_color_h=”{“id“:“Main accent color“,“color“:“#2a327e“}” bg_color_h=”{“solid“:{“id“:“Light text color“,“color“:“#ffffff“}}” el_class=”buttonwrap”][\/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_empty_space height=”50px”][vc_text_element force_color=”yes” css_animation=”” color=”{“id“:“Main accent color“,“color“:“#2a327e“}”]<\/p>\n

\n
\n

The False Lumen Embolization System\u00a0<\/span><\/h3>\n<\/div>\n<\/div>\n
\n
\n

Caution \u2013 INVESTIGATIONAL DEVICE, LIMITED TO INVESTIGATIONAL USE ONLY. This product is not commercially available.\u00a0<\/strong><\/p>\n

Intended Use: <\/strong>The False Lumen Embolization System is indicated for use in patients with subacute or chronic aortic dissection. After or during the primary entry tear repair procedure, the False Lumen Embolization System is intended to obstruct or reduce the rate of blood flow in the false lumen.<\/p>\n

The False Lumen Embolization System is intended for use by physicians trained and experienced in endovascular management of aortic dissection, embolization techniques, angiographic techniques, and interventional procedures. Standard techniques for placement of vascular access sheaths, introducer sheaths, and guidewires should be employed.<\/b><\/span><\/p>\n<\/div>\n<\/div>\n

\n
\n

MRI & Safety Information<\/h3>\n<\/div>\n<\/div>\n
\n

MR CONDITIONAL<\/u><\/strong>
\nNon-clinical testing and MRI simulations were performed to evaluate the Implant in its worst-case (largest) configuration. Non-clinical testing demonstrated that the Implant is MR Conditional. A patient implanted with one or more Implants may be scanned safely in an MR system under the following conditions:<\/p>\n

    \n
  • \n
      \n
    • Static, horizontal, magnetic field of 1.5-Tesla or 3-Tesla, only<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
        \n
      • Maximum spatial gradient magnetic field of 10,000-gauss\/cm (100-T\/m)<\/li>\n
      • Maximum whole body averaged (WBA) specific absorption rate (SAR) in Normal Operating Mode<\/li>\n<\/ul>\n
          \n
        • \n
            \n
          • 1.5-Tesla\/64-MHz, WBA SAR, 1-W\/kg<\/li>\n
          • 3-Tesla\/128MHz, WBA SAR, 2-W\/kg<\/li>\n<\/ul>\n<\/li>\n
          • Scan Duration and Wait Time\n
              \n
            • 1.5-Tesla\/64-MHz, WBA SAR, 1-W\/kg:\u00a0 10 minutes continuous RF exposure, followed by 20 minute wait period, repeated twice in 60 minutes. Alternatively, the patient may undergo 15 minutes continuous RF exposure, followed by a 45 minute wait period (once per 60 minutes).<\/li>\n
            • 3-Tesla\/128-MHz, WBA SAR, 2-W\/kg:\u00a0 60 minutes continuous RF exposure (i.e., per pulse sequence or back-to-back sequences\/series without breaks).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n

              Under the scan conditions defined, the Implant is expected to produce a temperature rise of less than or equal to 6\u00b0C.<\/p>\n

              In non-clinical testing, the image artifact caused by the Implant extends approximately 4 mm from the device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.<\/p>\n<\/div>\n

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