{"id":179998,"date":"2021-02-07T01:48:43","date_gmt":"2021-02-07T01:48:43","guid":{"rendered":"http:\/\/facfox.com\/news\/?p=179998"},"modified":"2021-04-06T03:29:58","modified_gmt":"2021-04-06T03:29:58","slug":"fda-approves-first-patient-specific-3d-printed-talus-implant-in-the-us","status":"publish","type":"post","link":"https:\/\/facfox.com\/news\/fda-approves-first-patient-specific-3d-printed-talus-implant-in-the-us\/","title":{"rendered":"FDA Approves First Patient-Specific, 3D Printed Talus Implant in the US"},"content":{"rendered":"

The FDA has approved its first 3D print<\/a>ed talus metal implant designed to replace the main bone in the ankle joint connecting the leg to the foot. The agency issued a green light to New Jersey-based Additive Orthopaedics under humanitarian use for the treatment of avascular necrosis, a progressive condition that can lead to the death of bone tissue following a sudden injury that cuts off blood flow, such as a broken bone or dislocation.<\/p>\n

<\/p>\n

The cobalt-chromium alloy implant is custom-made to match each patient\u2019s talus bone using data taken from a CT scan. It\u2019s designed to potentially spare them from other surgical procedures that may fuse ankle and foot bones together and leave the joint fixed in place.<\/p>\n

The 3D print<\/a>ed talus implant<\/h2>\n

\u201cAvascular necrosis of the ankle, while a rare condition, is a serious and potentially debilitating one that causes pain and can lead to inhibited motion of the ankle joint, and in some cases, removal of part<\/a> of the leg,\u201d<\/p>\n

\"\"
This picture shows avascular necrosis of the talus. (Credit: SciELO)<\/figcaption><\/figure>\n

said Capt. Raquel Peat, Ph.D., of the U.S. Public Health Service and director of the FDA\u2019s orthopedic device office.<\/p>\n

\n
\n

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\u201cToday\u2019s action provides patients with a treatment option that could potentially reduce pain, retain range of motion of their joint and improve quality of life,\u201d Peat said.<\/p>\n

The agency granted Additive\u2019s talus spacer implant a humanitarian use exemption, offered for devices aimed at conditions that affect fewer than 8,000 people annually.<\/p>\n

A clinical trial of 31 patients that received 32 replacement procedures\u2014with one part<\/a>icipant having operations on both ankles\u2014found pain decreased over the three years following surgery. Three part<\/a>icipants needed additional surgeries during that time, according to the FDA.<\/p>\n

The company said it plans to begin the implant\u2019s commercial launch immediately.<\/p>\n

<\/div>\n

 <\/p>\n

* This article is reprinted from 3D Printing Media Network<\/a>. If you are involved in infringement, please contact us to delete it.<\/p>\n

<\/i> Author: Davide Sher<\/p>\n","protected":false},"excerpt":{"rendered":"

The FDA has approved its first 3D printed talus metal implant designed to replace the main bone in the ankle joint connecting the leg to the foot. The agency issued a green light to New Jersey-based Additive Orthopaedics under humanitarian use for the treatment of avascular necrosis, a progressive condition that can lead to the death of bone tissue following a sudden injury that cuts off blood flow, such as a broken bone or dislocation.<\/p>\n","protected":false},"author":3,"featured_media":184722,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"fifu_image_url":"https:\/\/facfox.com\/news\/wp-content\/uploads\/2021\/02\/Pasted-into-FDA-Approves-First-Patient-Specific-3D-Printed-Talus-Implant-in-the-US-.png","fifu_image_alt":"FDA Approves First Patient-Specific, 3D Printed Talus Implant in the US","footnotes":""},"categories":[195],"tags":[24,3550,129,3385],"class_list":["post-179998","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-3d-printing","tag-implants","tag-medical","tag-orthopedic"],"yoast_head":"\nFDA Approves First Patient-Specific, 3D Printed Talus Implant in the US - FacFox News<\/title>\n<meta name=\"description\" content=\"The FDA has approved its first 3D printed talus metal implant designed to replace the main bone in the ankle joint connecting the leg to the foot. 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