{"id":3362,"date":"2021-07-21T09:15:00","date_gmt":"2021-07-21T16:15:00","guid":{"rendered":"https:\/\/allocare.caredx.com\/?p=3362"},"modified":"2022-08-16T14:13:51","modified_gmt":"2022-08-16T21:13:51","slug":"fda-advisory-committee-unanimously-agrees-donor-liver-portable-system-is-safe-effective","status":"publish","type":"post","link":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/indexphp\/post\/2021\/07\/21\/fda-advisory-committee-unanimously-agrees-donor-liver-portable-system-is-safe-effective\/","title":{"rendered":"FDA advisory committee unanimously agrees donor liver portable system is safe, effective"},"content":{"rendered":"<span class=\"simplefavorite-button has-count loading\" data-postid=\"3362\" data-siteid=\"1\" data-groupid=\"1\" data-favoritecount=\"0\" style=\"\">Loading<span class=\"sf-icon-spinner-wrapper\"><i class=\"sf-icon-spinner\"><\/i><\/span><\/span>\n<p>&#8220;The FDA\u2019s Gastroenterology and Urology Devices Panel, Medical Devices Advisory Committee voted unanimously that a portable system for near-normothermic continuous perfusion of donor livers with perfusate was safe and effective.<\/p>\n\n\n\n<p>The system will be prepared by hospital pharmacy and include compatible packed red blood cells.<\/p>\n\n\n\n<p>The panel addressed three questions related to the premarket approval of the device\u00a0Organ Care System Liver System\u00a0(TransMedics). The entire 14-member panel voted that the device is safe, all voted that the device is effective and voted 12 to 1 with 1 abstaining that the benefits of the OCS Liver System outweigh the risks.&#8221;<\/p>\n\n\n\n<p>Read more, <a href=\"https:\/\/www.healio.com\/news\/gastroenterology\/20210715\/fda-advisory-committee-unanimously-agrees-donor-liver-portable-system-is-safe-effective\">here<\/a>.<\/p>\n<span class=\"simplefavorite-button has-count loading\" data-postid=\"3362\" data-siteid=\"1\" data-groupid=\"1\" data-favoritecount=\"0\" style=\"\">Loading<span class=\"sf-icon-spinner-wrapper\"><i class=\"sf-icon-spinner\"><\/i><\/span><\/span>","protected":false},"excerpt":{"rendered":"<p>Loading &#8220;The FDA\u2019s Gastroenterology and Urology Devices Panel, Medical Devices Advisory Committee voted unanimously that a portable system for near-normothermic continuous perfusion of donor livers with perfusate was safe and &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/indexphp\/post\/2021\/07\/21\/fda-advisory-committee-unanimously-agrees-donor-liver-portable-system-is-safe-effective\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA advisory committee unanimously agrees donor liver portable system is safe, effective&#8221;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":1360,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_EventAllDay":false,"_EventTimezone":"","_EventStartDate":"","_EventEndDate":"","_EventStartDateUTC":"","_EventEndDateUTC":"","_EventShowMap":false,"_EventShowMapLink":false,"_EventURL":"","_EventCost":"","_EventCostDescription":"","_EventCurrencySymbol":"","_EventCurrencyCode":"","_EventCurrencyPosition":"","_EventDateTimeSeparator":"","_EventTimeRangeSeparator":"","_EventOrganizerID":[],"_EventVenueID":0,"_OrganizerEmail":"","_OrganizerPhone":"","_OrganizerWebsite":"","_VenueAddress":"","_VenueCity":"","_VenueCountry":"","_VenueProvince":"","_VenueZip":"","_VenuePhone":"","_VenueURL":"","_VenueStateProvince":"","_VenueLat":"","_VenueLng":"","_tribe_blocks_recurrence_rules":"","_tribe_blocks_recurrence_description":"","_tribe_blocks_recurrence_exclusions":"","_ecp_custom_2":"","footnotes":""},"categories":[45,912],"tags":[26,17],"post_format":[],"Dislikes":"","Likes":"","simplefavorites_count":"","views":"1335","post_likes_plusCounter":"","post_dislikes_plusCounter":"","acf":[],"_links":{"self":[{"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/posts\/3362"}],"collection":[{"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/comments?post=3362"}],"version-history":[{"count":1,"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/posts\/3362\/revisions"}],"predecessor-version":[{"id":3363,"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/posts\/3362\/revisions\/3363"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/media\/1360"}],"wp:attachment":[{"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/media?parent=3362"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/categories?post=3362"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/tags?post=3362"},{"taxonomy":"post_format","embeddable":true,"href":"https:\/\/app-allocare-wordpress-linux-prod.azurewebsites.net\/index.php\/wp-json\/wp\/v2\/post_format?post=3362"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}