[et_pb_section fb_built=”1″ _builder_version=”4.9.3″ _module_preset=”default” background_color=”#005ca8″ min_height=”96px” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” global_module=”13944″ saved_tabs=”all” global_colors_info=”{}”][et_pb_row _builder_version=”4.9.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.9.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_search placeholder=”BEGIN YOUR SEARCH HERE…” button_color=”#e2a632″ placeholder_color=”#424242″ _builder_version=”4.14.2″ _module_preset=”default” form_field_background_color=”#FFFFFF” form_field_text_color=”#000000″ button_text_color=”#ffffff” border_width_all=”0px” global_colors_info=”{}”][\/et_pb_search][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.9.0″ _module_preset=”default” background_enable_color=”off” global_colors_info=”{}”][et_pb_fullwidth_post_title author=”off” comments=”off” featured_image=”off” text_background=”on” text_bg_color=”#FFFFFF” _builder_version=”4.9.0″ _module_preset=”default” use_background_color_gradient=”on” background_color_gradient_start=”#005ca8″ background_color_gradient_end=”rgba(0,92,168,0.31)” background_color_gradient_overlays_image=”on” background_image=”https:\/\/mdic-spi.org\/wp-content\/uploads\/2021\/02\/circuitry-header-background-scaled.jpg” global_colors_info=”{}”][\/et_pb_fullwidth_post_title][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Patient Introduction for Article” module_class=”article-patient-intro” _builder_version=”4.9.0″ _module_preset=”default” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][et_pb_row admin_label=”Patient Perspective – Row Toggle” _builder_version=”4.9.0″ _module_preset=”default” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.7.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_toggle title=”Patient Introduction ” open=”on” open_toggle_text_color=”#FFFFFF” icon_color=”#FFFFFF” use_icon_font_size=”on” icon_font_size=”23px” open_icon_color=”#FFFFFF” open_use_icon_font_size=”on” open_icon_font_size=”23px” _builder_version=”4.14.2″ _module_preset=”default” title_text_color=”#FFFFFF” title_level=”h3″ body_text_color=”#FFFFFF” background_color=”#85bfd1″ text_orientation=”left” hover_enabled=”0″ border_width_all=”0px” global_colors_info=”{}” sticky_enabled=”0″]Some patients may require dialysis if their own bodies are unable to filter toxins from their blood. Hemodialysis is a type of dialysis in which blood is pumped from the body through a filter and then back into the body. Typically, in-clinic treatment requires patients to travel multiple times per week to a dialysis center to receive dialysis. In the option of home hemodialysis (HHD), the treatment takes place at the patient\u2019s home (or outside of a clinical setting). Home hemodialysis can be a more convenient option for some patients because they do not have to travel to the clinic and can have a flexible schedule to dialyze on their own time. Previously, FDA had only cleared HHD for use outside the clinical setting when a patient was with a care partner. Patients that lived alone or lost access to a care partner were not eligible for HHD and could only receive dialysis in-center. Home hemodialysis cleared for solo use (solo HHD) could increase treatment options for those dialysis patients who do not have care partners present and willing to accept the associated risks of solo treatment. This case study discusses how the patient preference survey data were considered in the FDA CDRH\u2019s decision to clear an expanded indication for NxStage\u2019s home hemodialysis device. [\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.6.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.6.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.6.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Article Summary” _builder_version=”4.14.2″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
Home hemodialysis device manufacturer, NxStage, used the MDIC Patient-Centered Benefit-Risk (PCBR)<\/a> Framework as a guide in developing a patient preference survey to quantify the acceptable risk of the patient performing hemodialysis at home alone versus at a dialysis center. Data from that survey were considered in the FDA CDRH\u2019s decision to clear an expanded indication for NxStage\u2019s home hemodialysis device. This article reviews how NxStage incorporated quantitative patient preference data in its 510(k) submission, which ultimately received clearance from the FDA.<\/p>\n [\/et_pb_text][et_pb_button button_url=”\/wp-content\/uploads\/2021\/02\/Case-Study-Using-the-MDIC-Patient-Centered-Benefit-Risk-Framework-to-Support-an-Expanded-Indication.pdf” url_new_window=”on” button_text=”Download the Case Study %91PDF%93″ button_alignment=”center” admin_label=”Button – Download the Case Study %91PDF%93″ _builder_version=”4.9.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.8.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.8.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”h5 – Jump directly to a specific note within the PDF Report:” _builder_version=”4.8.1″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n [\/et_pb_text][et_pb_toggle title=”GUIDANCE” open=”on” admin_label=”Toggle – GUIDANCE” _builder_version=”4.9.1″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n Approach, pg. 4<\/a> [\/et_pb_toggle][et_pb_toggle title=”REGULATORY DECISION” open=”on” admin_label=”Toggle – REGULATORY DECISION” _builder_version=”4.9.1″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n Summary, pg. 2<\/a> [\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":" Some patients may require dialysis if their own bodies are unable to filter toxins from their blood. Hemodialysis is a type of dialysis in which blood is pumped from the body through a filter and then back into the body. Typically, in-clinic treatment requires patients to travel multiple times per week to a dialysis center […]<\/p>\n","protected":false},"author":4,"featured_media":13447,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[15,8],"tags":[25,56],"yoast_head":"\nJump directly to a specific note within the PDF Report:<\/h5>\n
Lessons Learned, pg. 5<\/a><\/p>\n
Regulatory Science Opportunity, pg. 2<\/a>
Outcome, pg. 5<\/a>
Lessons Learned, pg. 5<\/a><\/p>\n