{"id":1409,"date":"2022-01-18T15:07:27","date_gmt":"2022-01-18T14:07:27","guid":{"rendered":"http:\/\/localhost\/2022\/01\/18\/press-release-fda-clearance\/"},"modified":"2022-06-01T15:36:30","modified_gmt":"2022-06-01T13:36:30","slug":"press-release-fda-clearance","status":"publish","type":"post","link":"https:\/\/www.endotools.be\/us-en\/2022\/01\/18\/press-release-fda-clearance\/","title":{"rendered":"Press release: FDA Clearance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"1409\" class=\"elementor elementor-1409 elementor-116\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-73cb8fec elementor-section-full_width elementor-section-height-min-height elementor-section-height-default elementor-section-items-middle\" data-id=\"73cb8fec\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;waves&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" aria-hidden=\"true\" data-negative=\"false\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 1000 100\" preserveAspectRatio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M421.9,6.5c22.6-2.5,51.5,0.4,75.5,5.3c23.6,4.9,70.9,23.5,100.5,35.7c75.8,32.2,133.7,44.5,192.6,49.7\n\tc23.6,2.1,48.7,3.5,103.4-2.5c54.7-6,106.2-25.6,106.2-25.6V0H0v30.3c0,0,72,32.6,158.4,30.5c39.2-0.7,92.8-6.7,134-22.4\n\tc21.2-8.1,52.2-18.2,79.7-24.2C399.3,7.9,411.6,7.5,421.9,6.5z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-481dccb8\" data-id=\"481dccb8\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5edaac6f elementor-widget elementor-widget-heading\" data-id=\"5edaac6f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Press release: FDA Clearance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-48d6828 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"48d6828\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f7d5069\" data-id=\"f7d5069\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8127175 elementor-align-left elementor-widget elementor-widget-global elementor-global-472 elementor-widget-post-info\" data-id=\"8127175\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-d9dfd61 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.endotools.be\/us-en\/2022\/01\/18\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\t<time>January 18, 2022<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a90582f elementor-widget elementor-widget-heading\" data-id=\"a90582f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ENDOMINA\u00ae SYSTEM, A NEW SUTURING TOOL FOR USE BY GASTROENTEROLOGISTS RECEIVES <br> FDA CLEARANCE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cd3fede elementor-widget elementor-widget-text-editor\" data-id=\"cd3fede\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><em>Endo Tools Therapeutics proprietary platform offers competitive technology designed to enable less invasive procedures<\/em><\/p><p>Gosselies, Belgium, January 18, 2022 \u2013 Endo Tools Therapeutics (ETT), developers of advanced endoscopic medical devices for use by gastroenterologists, today announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of the endomina\u00ae system, designed for endoscopic placement of suture(s) and approximation of soft tissue in the gastrointestinal tract on adult population.<\/p><p>The endomina system is comprised of a universal triangulation platform and an instrument for tissue piercing and approximation (TAPES). It can be affixed to various tested standard endoscopes, providing a bendable therapeutic channel that can move independently. This degree of freedom enables the gastroenterologist to perform endoscopic suturing similar to laparoscopy interventions but using only natural orifice (mouth), providing an incisionless procedure.<\/p><p>\u201cThis technology is a very meaningful addition to our armamentarium for performing procedures requiring suturing,\u201d said Dr Ivo Bo\u0161koski from Policlinico Gemelli, Rome, Italy. \u201cThe endomina system represents a significant advancement in interventional gastroenterology which could expand treatment options for patients.\u201d<\/p><p>The endomina system is CE marked and commercially available outside the United States. In addition, the system is in European clinical studies for a wide range of procedures in the digestive tract such as bariatric interventions, Gastroesophageal Reflux Disease (GERD) or Endoscopic Full Thickness Resection (EFTR).<\/p><p>\u201cWe are delighted to bring this innovative and disruptive technology to the U.S. market,\u201d said Alexandre Chau, chief executive office, Endo Tools Therapeutics. \u201cDeveloped with physician needs in mind, the endomina system was designed to enable physicians to perform endoscopic suturing similar to laparoscopic procedures, but without an incision.\u201d<\/p><p>The company plans to have a limited market release of the endomina system in the U.S. in the first half of 2022, followed by a larger market release later in the year. \u201cWe are very excited to soon have the endomina system as part of our portfolio so we can continue to offer less invasive cutting-edge technologies to treat our patients,\u201d said Dr. Shelby Sullivan, University of Colorado Medicine in Denver, Colorado.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-70706fb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"70706fb\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b5fca89\" data-id=\"b5fca89\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d078742 elementor-widget elementor-widget-heading\" data-id=\"d078742\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">About Endo Tools Therapeutics<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-db3b797 elementor-widget elementor-widget-text-editor\" data-id=\"db3b797\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Located in Gosselies, Belgium, Endo Tools Therapeutics S.A. (ETT) mission is to develop advanced, incisionless, minimally invasive medical devices for gastroenterologists to use with standard endoscopes. The company targets indications that cannot be performed with standard gastroscopes, such as endoscopic suturing and tissue apposition. ETT closed $9.5 million in series D funding in January 2021. More than 500 procedures have already been performed with the company\u2019s devices globally.<\/p><p><br>For more information, please visit <a href=\"https:\/\/www.endotools.be\/us-en\/\">www.endotools.be<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6927b15 elementor-section-content-bottom elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6927b15\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-b2aba13\" data-id=\"b2aba13\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fb36016 elementor-widget elementor-widget-text-editor\" data-id=\"fb36016\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Press Contact<br>Katie Arnold \u2013 US contact<br>SPRIG Consulting, LLC<br>katie@sprigconsulting.com<br>+1 408-805-0520 (US)<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44c42cb elementor-share-buttons--view-icon elementor-share-buttons--skin-minimal elementor-share-buttons--shape-circle elementor-grid-0 elementor-share-buttons--color-official elementor-widget elementor-widget-share-buttons\" data-id=\"44c42cb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"share-buttons.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-grid\">\n\t\t\t\t\t\t\t\t<div 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[&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":1173,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[30],"tags":[],"class_list":["post-1409","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized-us-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Press release: FDA Clearance - endotools<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.endotools.be\/us-en\/2022\/01\/18\/press-release-fda-clearance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Press release: FDA Clearance - endotools\" \/>\n<meta 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