{"id":4337,"date":"2020-11-10T19:01:40","date_gmt":"2020-11-10T18:01:40","guid":{"rendered":"https:\/\/www.icotec-medical.com\/icotec-ag-receives-fda-clearance-for-the-vader-pedicle-system-with-bone-cement-augmentation\/"},"modified":"2023-03-27T20:36:52","modified_gmt":"2023-03-27T18:36:52","slug":"icotec-ag-receives-fda-clearance-for-the-vader-pedicle-system-with-bone-cement-augmentation","status":"publish","type":"post","link":"https:\/\/www.icotec-medical.com\/en-us\/news\/icotec-ag-receives-fda-clearance-for-the-vader-pedicle-system-with-bone-cement-augmentation\/","title":{"rendered":"2020-11-10: icotec ag Receives FDA Clearance for the VADER<sup>\u00ae<\/sup> Pedicle System with Bone Cement Augmentation"},"content":{"rendered":"\n<h4 class=\"wp-block-heading\"><strong>November 10, 2020 \u2013 Altstaetten, Switzerland \u2013 icotec ag, the leading medical device manufacture of Carbon\/PEEK spinal implants, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance to market the VADER<sup>\u00ae<\/sup>&nbsp;Pedicle System for use with bone cement for augmentation or without.<\/strong><\/h4>\n\n\n\n<p>The<strong> <a href=\"https:\/\/www.icotec-medical.com\/en-us\/implants\/vader-pedicle-system\/\">VADER<sup>\u00ae<\/sup>&nbsp;Pedicle System<\/a><\/strong> is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.<\/p>\n\n\n\n<p>The system can be used by surgeons with <strong>icotec\u2019s state-of-the art standard surgical technique<\/strong> and has the ability to be used in either open, <strong>minimally invasive or percutaneous surgical procedures<\/strong> involving the thoracic or lumbar spine. The screw\u2019s fenestration allows for bone cement augmentation to increase stability in patients with compromised bone quality.<\/p>\n\n\n<div id=\"quotes\" class=\"\">\n\n      <div class=\"quote \">\n      <div class=\"container\">\n        \n                \n                \n          <figure style=\"background-image:url(https:\/\/www.icotec-medical.com\/wp-content\/uploads\/2021\/10\/rost_Sommer-2022-e1677613818245-300x300.png);\"><\/figure>\n        \n                \n        <div class=\"text\">\n          \n          <blockquote>\n            \u201cWe are so proud to present today the VADER<sup>\u00ae<\/sup> product family which represents our continued commitment to develop and commercialize spinal implants made from our radiotransparent, nonmetallic BlackArmor<sup>\u00ae<\/sup> material that produces minimal image artifact while eliminating shielding and scattering of radiation during oncology treatments.\u201d          <\/blockquote>\n          <div class=\"author\">\n            <div class=\"name\">Roger Stadler<\/div>\n            <div class=\"position\">Group CEO\/CHO<\/div>\n          <\/div>\n          \n        <\/div>\n        \n              \n      <\/div>\n    <\/div>\n    \n<\/div>\n\n<script>\n\n  jQuery(document).ready( function($){\n  \n    $(\"#quotes\").slick({\n      slidesToShow: 1,\n      slidesToScroll: 1,\n      fade: true,\n      loop: true,\n      infinite: false,\n      arrows: true,\n      adaptiveHeight: true,\n      dots: false,\n      autoplay: false,\n      autoplaySpeed: 4000,\n    });\n    \n  });\n\n<\/script>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" width=\"576\" height=\"676\" src=\"https:\/\/www.icotec-medical.com\/wp-content\/uploads\/2020\/11\/pic_2_Web-1.png\" alt=\"icotec ag\" class=\"wp-image-3373\" srcset=\"https:\/\/www.icotec-medical.com\/wp-content\/uploads\/2020\/11\/pic_2_Web-1.png 576w, https:\/\/www.icotec-medical.com\/wp-content\/uploads\/2020\/11\/pic_2_Web-1-256x300.png 256w\" sizes=\"(max-width: 576px) 100vw, 576px\" \/><\/figure>\n\n\n\n<p>The VADER<sup>\u00ae<\/sup>&nbsp;pedicle screw 6.0 is manufactured with <strong><a href=\"https:\/\/www.icotec-medical.com\/en-us\/blackarmor\/\">BlackArmor<sup>\u00ae<\/sup><\/a><\/strong>, a Carbon\/PEEK material, and <strong>Ti-iT<sup>\u00ae<\/sup><\/strong>&nbsp;pure titanium coating on the screw shaft. The radio-transparency of the VADER<sup>\u00ae<\/sup>&nbsp;pedicle screw 6.0 assists in the planning, application, and follow-up care of radiotherapy for patients with spinal tumors.<\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full\"><img decoding=\"async\" width=\"705\" height=\"551\" src=\"https:\/\/www.icotec-medical.com\/wp-content\/uploads\/2020\/11\/pic_3_Web-1.png\" alt=\"icotec ag\" class=\"wp-image-3370\" srcset=\"https:\/\/www.icotec-medical.com\/wp-content\/uploads\/2020\/11\/pic_3_Web-1.png 705w, https:\/\/www.icotec-medical.com\/wp-content\/uploads\/2020\/11\/pic_3_Web-1-300x234.png 300w\" sizes=\"(max-width: 705px) 100vw, 705px\" \/><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\">About icotec ag<\/h4>\n\n\n\n<p>Founded in 1999, icotec ag is a family-owned SME based in Altstaetten, Switzerland. icotec develops, manufactures, and distributes nonmetallic spinal implants made from BlackArmor<sup>\u00ae<\/sup>.<\/p>\n\n\n\n<p>icotec\u2019s proprietary BlackArmor<sup>\u00ae<\/sup>&nbsp;material is made up of continuous carbon fibers combined with polyether ether ketone (PEEK) and is manufactured with icotec\u2019s unique injection moulding CFM (composite flow molding) manufacturing technology.<\/p>\n\n\n\n<p>With over 15 years of clinical success and more than 40,000 implanted products made from the unique BlackArmor<sup>\u00ae<\/sup>&nbsp;material, icotec ag is the leading provider of Carbon\/PEEK spinal implants. For further information, visit our website (<a href=\"http:\/\/www.icotec-medical.com\/\">www.icotec-medical.com<\/a>) or contact us at&nbsp;<a href=\"&#109;&#x61;&#105;&#x6c;t&#x6f;:&#109;&#x65;&#100;&#x69;&#97;&#x40;i&#x63;o&#116;&#x65;&#99;&#x2d;m&#x65;d&#x69;&#x63;&#97;&#x6c;&#46;&#x63;o&#x6d;\">&#x6d;&#x65;&#x64;&#105;&#97;&#64;ic&#x6f;&#x74;&#x65;&#x63;&#45;&#109;ed&#x69;&#x63;&#x61;&#x6c;&#46;&#99;om<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>November 10, 2020 \u2013 Altstaetten, Switzerland \u2013 icotec ag, the leading medical device manufacture of Carbon\/PEEK spinal implants, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance to market the VADER\u00ae&nbsp;Pedicle System for use with bone cement for augmentation or without. The VADER\u00ae&nbsp;Pedicle System is intended to restore the integrity of the spinal column [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":3220,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4337","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-unkategorisiert"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Clearance: VADER\u00ae Pedicle System with Bone Cement Augmentation | icotec<\/title>\n<meta name=\"description\" content=\"icotec ag announces the U.S. Food and Drug Administration (FDA) 510(k) clearance to market the VADER\u00ae Pedicle System for use with bone cement for augmentation or without.\" \/>\n<meta name=\"robots\" content=\"index, follow, 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