{"id":36879,"date":"2025-11-07T03:11:04","date_gmt":"2025-11-07T03:11:04","guid":{"rendered":"https:\/\/g-medtech.com\/news\/?p=36879"},"modified":"2025-11-07T03:17:43","modified_gmt":"2025-11-07T03:17:43","slug":"nitinotes-gains-ce-mark-for-endozip-a-fully-automated-suturing-system-for-endoscopic-sleeve-gastroplasty","status":"publish","type":"post","link":"https:\/\/g-medtech.com\/news\/pl\/nitinotes-gains-ce-mark-for-endozip-a-fully-automated-suturing-system-for-endoscopic-sleeve-gastroplasty\/","title":{"rendered":"Nitinotes Gains CE Mark for EndoZip, a Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><a href=\"https:\/\/g-medtech.com\/database\/medtech-players\/index\/nitinotes\/\" target=\"_blank\" rel=\"noreferrer noopener\">Nitinotes<\/a>, a medical device company based in Caesarea, Israel, has received CE Mark approval for its EndoZip\u2122 System, the first fully automated suturing platform for endoscopic sleeve gastroplasty (ESG). The regulatory milestone paves the way for the company to launch its obesity treatment technology across the European Union and other CE Mark-recognized markets.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Obesity remains a major global health concern, affecting more than 650 million adults worldwide. For many patients, there is a gap between medical therapy options, such as GLP-1-based treatments, and traditional bariatric surgery. ESG has emerged as a minimally invasive alternative for patients with a body mass index (BMI) between 30 and 40 kg\/m\u00b2 who have not achieved sufficient results through diet, exercise, or medication.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The EndoZip system automates the suturing process during ESG, allowing a single physician to perform the procedure more efficiently in an outpatient setting. In contrast to manual systems that require two operators and advanced endoscopic skills, EndoZip enables faster, consistent, and reproducible results with a shorter learning curve. The approach is designed to make ESG more accessible and cost-effective for healthcare providers and patients.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cCE Mark approval of EndoZip is a pivotal milestone for Nitinotes,\u201d said Lloyd Diamond, Chief Executive Officer of Nitinotes. \u201cThis achievement validates the safety and performance of our technology and paves the way for commercialization in Europe. With EndoZip, we have the potential to dramatically expand patient access to a safe, durable, minimally invasive obesity treatment while creating significant value for providers and healthcare systems.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nitinotes plans to introduce EndoZip in select European centers of excellence to build clinical experience and gather real-world evidence before expanding further across the region. The company is also preparing for a pivotal U.S. IDE trial to support an eventual FDA submission, aiming to bring its automated ESG technology to the American market.<\/p>","protected":false},"excerpt":{"rendered":"<p>Israel-based Nitinotes has received CE Mark approval for EndoZip\u2122, the first fully automated suturing system for endoscopic sleeve gastroplasty, enabling European commercialization of a faster, simpler ESG procedure.<\/p>","protected":false},"author":2,"featured_media":36880,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"colormag_page_layout":"default_layout","footnotes":""},"categories":[488,6,25,677],"tags":[704],"class_list":["post-36879","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-breaking-news","category-europe","category-products-technologies","category-surgical","tag-ce-mark"],"_links":{"self":[{"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/posts\/36879","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/comments?post=36879"}],"version-history":[{"count":1,"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/posts\/36879\/revisions"}],"predecessor-version":[{"id":36881,"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/posts\/36879\/revisions\/36881"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/media\/36880"}],"wp:attachment":[{"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/media?parent=36879"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/categories?post=36879"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/pl\/wp-json\/wp\/v2\/tags?post=36879"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}