{"id":1459,"date":"2022-12-05T13:27:54","date_gmt":"2022-12-05T18:27:54","guid":{"rendered":"https:\/\/research.ncsu.edu\/win\/?p=1459"},"modified":"2023-11-09T14:49:51","modified_gmt":"2023-11-09T19:49:51","slug":"deep-blue-medical-advances-announces-fda-clearance","status":"publish","type":"post","link":"https:\/\/research.ncsu.edu\/win\/deep-blue-medical-advances-announces-fda-clearance\/","title":{"rendered":"Deep Blue Medical Advances Announces FDA Clearance for Sublay Application in Hernia Surgery, Enabling Broader Use of T-Line Hernia Mesh"},"content":{"rendered":"<div class=\"wp-block-ncst-buttons\"><div class=\"wp-block-ncst-button\"><a href=\"https:\/\/www.prnewswire.com\/news-releases\/deep-blue-medical-advances-announces-fda-clearance-for-sublay-application-in-hernia-surgery-enabling-broader-use-of-t-line-hernia-mesh-301694339.html\/\" class=\"btn ncst-block__button-link\" data-ncst-lightbox=\"false\" data-ua-cat=\"Button Block\" data-ua-action=\"Button Click\" data-ua-label=\"https:\/\/www.prnewswire.com\/news-releases\/deep-blue-medical-advances-announces-fda-clearance-for-sublay-application-in-hernia-surgery-enabling-broader-use-of-t-line-hernia-mesh-301694339.html\/\"><span class=\"text\">Read Full Article <\/span><span class=\"arrow-indicator\"><svg \n\tclass=\"wolficon wolficon-arrow-right-bold\"\n\trole=\"img\"\n\taria-hidden=\"1\">\n\t\t<use xlink:href=\"#wolficon-arrow-right-bold\"><\/use>\n<\/svg>\n<\/span><\/a><\/div>\n\n<\/div>\n\n\n\n<p><span class=\"legendSpanClass\" style=\"font-size: 1.125rem; font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, Oxygen-Sans, Ubuntu, Cantarell, 'Helvetica Neue', sans-serif;\"><span class=\"xn-location\">DURHAM, N.C.<\/span><\/span><span style=\"font-size: 1.125rem; font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, Oxygen-Sans, Ubuntu, Cantarell, 'Helvetica Neue', sans-serif;\">,\u00a0<\/span><span class=\"legendSpanClass\" style=\"font-size: 1.125rem; font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, Oxygen-Sans, Ubuntu, Cantarell, 'Helvetica Neue', sans-serif;\"><span class=\"xn-chron\">Dec. 5, 2022<\/span><\/span><span style=\"font-size: 1.125rem; font-family: -apple-system, BlinkMacSystemFont, 'Segoe UI', Roboto, Oxygen-Sans, Ubuntu, Cantarell, 'Helvetica Neue', sans-serif;\">\u00a0\/PRNewswire\/ &#8212; Deep Blue Medical Advances announced today it has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its T-Line\u00ae\u00a0Hernia Mesh for the sublay technique in open hernia surgery. This significantly expands the patient population that can be treated with T-Line and experience the unique benefits of its novel design and application.<\/span><\/p>\n<article class=\"news-release inline-gallery-template\">\n<section class=\"release-body container \">\n<div class=\"row\">\n<div class=\"col-lg-10 col-lg-offset-1\">\n<div class=\"pull-right inline-gallery-container col-md-8 col-sm-7 col-xs-12\">\n<div class=\"gallery inline-gallery\">\n<div class=\"row\">\n<div class=\"col-sm-12\">\n<aside class=\"pull-quote\">This significantly expands the patient population that can be treated with T-Line mesh<a class=\"btn btn-default btn-twitter\" data-tweet-text=\"This significantly expands the patient population that can be treated with T-Line mesh\" data-twitter-share-url=\"https:\/\/www.prnewswire.com\/news-releases\/deep-blue-medical-advances-announces-fda-clearance-for-sublay-application-in-hernia-surgery-enabling-broader-use-of-t-line-hernia-mesh-301694339.html\"><i class=\"fab fab-twitter mr-sm\"><\/i>Tweet this<\/a><\/aside>\n<\/div>\n<div class=\"col-sm-12 clearfix\">\u00a0<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>The sublay procedure is the most widely performed open surgery ventral hernia repair method for large incisional hernias. With this clearance, the T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sublay approach in adults.<\/p>\n<p>Deep Blue&#8217;s T-Line mesh design includes novel mesh extensions that provide superior anchor strength designed to prevent mesh fixation failure. T-Line&#8217;s design offers the surgeon the ability to provide optimal mesh tension adjustment and many other potential surgical and clinical advantages compared to conventional mesh application.<\/p>\n<p>&#8220;Many hernia surgeons prefer the sublay technique for hernia repair and have been eager to use T-Line for this, so we are thrilled to receive this clearance to enable broader clinical use,&#8221; said Dr.\u00a0<span class=\"xn-person\">Howard Levinson<\/span>, Deep Blue&#8217;s founder and Chief Medical Officer.<\/p>\n<p>&#8220;There are 4\u20135 million abdominal incisions (laparotomies) performed annually in\u00a0<span class=\"xn-location\">the United States<\/span>\u00a0with hernias resulting after approximately 25% of these procedures<sup>1<\/sup>. Further, long-term ventral hernia repair failure rates are up to 32% using conventional mesh and 63% with suture repair only, creating a multibillion-dollar clinical cost to the US healthcare system<sup>2<\/sup>. Consequently, there are over 400,000 incisional hernia repairs performed each year in\u00a0<span class=\"xn-location\">the United States<\/span>\u00a0making it one of the five most common procedures performed by general surgeons<sup>1<\/sup>,&#8221; said CEO\u00a0<span class=\"xn-person\">Bill Perry<\/span>. &#8220;This expanded clinical indication allows our growing number of clinical sites to address this important \u00a0problem in significantly more patients with T-Line Hernia Mesh.&#8221;<\/p>\n<ol type=\"1\">\n<li>Harris HW\u00a0<i>Innovations for Incisional Hernia Prevention, J. of Abdom. Wall Surg<\/i>. (2022) 1:10945<\/li>\n<li>Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J.\u00a0<i>Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg<\/i>. (2004) Oct;240(4):578-83<\/li>\n<\/ol>\n<p><b>About Deep Blue Medical Advances:<\/b>\u00a0Established in 2015, Deep Blue Medical Advances is dedicated to addressing the unacceptably high rate of hernia recurrence and providing surgeons a superior surgical experience. Deep Blue Medical is commercializing T-Line\u00ae\u00a0Hernia Mesh and has a portfolio of additional hernia and surgical products in development.<\/p>\n<p>SOURCE Deep Blue Medical Advances<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=LA55643&amp;Transmission_Id=202212050900PR_NEWS_USPR_____LA55643&amp;DateId=20221205\" alt=\"\" \/><\/p>\n<\/div>\n<\/div>\n<\/section>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>Deep Blue Medical Advances announced today it has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its T-Line\u00ae\u00a0Hernia Mesh for the sublay technique in open hernia surgery. <\/p>\n","protected":false},"author":1119,"featured_media":125,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"ncst_custom_author":"","ncst_show_custom_author":false,"ncst_dynamicHeaderBlockName":"","ncst_dynamicHeaderData":"","ncst_content_audit_freq":"","ncst_content_audit_date":"","ncst_content_audit_display":false,"ncst_backToTopFlag":"","footnotes":""},"categories":[9],"tags":[56,122,123,59,47],"class_list":["post-1459","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-angel-investing","tag-deep-blue-medical-advances","tag-fda-clearance","tag-north-carolina-startups","tag-wolfpack-investor-network"],"displayCategory":null,"acf":{"ncst_posts_meta_modified_date":null},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.5 - 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