{"id":14569,"date":"2022-10-11T03:22:45","date_gmt":"2022-10-11T03:22:45","guid":{"rendered":"https:\/\/g-medtech.com\/news\/?p=14569"},"modified":"2025-08-18T05:01:34","modified_gmt":"2025-08-18T05:01:34","slug":"phagenesis-launches-phagenyx-neurostimulation-system-in-the-u-s","status":"publish","type":"post","link":"https:\/\/g-medtech.com\/news\/ko\/phagenesis-launches-phagenyx-neurostimulation-system-in-the-u-s\/","title":{"rendered":"Phagenesis Launches Phagenyx Neurostimulation System in the U.S."},"content":{"rendered":"<p class=\"wp-block-paragraph\"><a href=\"https:\/\/g-medtech.com\/database\/medtech-players\/index\/phagenesis\/\" target=\"_blank\" rel=\"noreferrer noopener\">Phagenesis<\/a> announced that the U.S. FDA had granted a De Novo request for the Phagenyx\u00ae Neurostimulation System, a first-of-its-kind therapy that uses pharyngeal electrical stimulation to restore swallowing control in patients with severe dysphagia post-stroke. The company is now preparing a targeted launch in the U.S.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Phagenyx System treats neurogenic dysphagia using pharyngeal electrical stimulation (PES) targeting the neurological components of swallowing coordination. Phagenyx therapy has demonstrated the best results when delivered at the earliest stages after injury to enhance neurorehabilitation and restore swallowing control.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#8220;There is limited awareness of the significance of dysphagia in the critical care setting following prolonged mechanical ventilation or tracheostomy,&#8221; says Dr. Wade Smith, Professor of Neurology at the University of California, San Francisco (UCSF). &#8220;Such patients cannot manage their own saliva, creating a high risk for aspiration and their safety. Phagenyx has the potential to treat patients early in the ICU which has been shown to accelerate recovery, reduce hospital length of stay and prevent downstream complications.&#8221;<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<iframe class=\"lazyload\" data-src=\"https:\/\/www.youtube.com\/embed\/PAjf5I1nmbo?feature=oembed\" title=\"Phagenyx\u00ae System Overview Long (English)\" width=\"800\" height=\"450\"  frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture\" allowfullscreen><\/iframe>\n<\/div><figcaption class=\"wp-element-caption\">Phagenyx\u00ae System Overview<\/figcaption><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">&#8220;The Phagenyx System is a next-generation therapy for neurogenic dysphagia that has been shown to deliver significant benefits in swallowing safety and swallowing efficiency, which have the potential to translate into substantial health economic benefits due to accelerated patient recovery,&#8221; commented Reinhard Krickl, Chief Executive Officer of <a href=\"https:\/\/www.g-medtech.com\/directory\/listings\/phagenesis\/\" target=\"_blank\" rel=\"noreferrer noopener\">Phagenesis<\/a>. &#8220;We are pleased with FDA&#8217;s decision to grant our de novo request and are eager to bring this new technology to the millions of patients in the US who suffer from post-stroke dysphagia and are desperate for a better solution.&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Phagenyx System is designated a Breakthrough Device by the FDA which reflects clear unmet needs in current dysphagia care. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Phagenyx is commercially available in Europe and is supported by numerous randomized controlled trials and larger-scale real world registries.<\/p>","protected":false},"excerpt":{"rendered":"<p>a first-of-its-kind therapy that uses pharyngeal electrical stimulation to restore swallowing control in patients with severe dysphagia post-stroke<\/p>","protected":false},"author":2,"featured_media":14570,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"colormag_page_layout":"default_layout","footnotes":""},"categories":[7,681,25],"tags":[687],"class_list":["post-14569","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-americas","category-care-therapy","category-products-technologies","tag-fda"],"_links":{"self":[{"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/posts\/14569","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/comments?post=14569"}],"version-history":[{"count":6,"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/posts\/14569\/revisions"}],"predecessor-version":[{"id":34457,"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/posts\/14569\/revisions\/34457"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/media\/14570"}],"wp:attachment":[{"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/media?parent=14569"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/categories?post=14569"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/ko\/wp-json\/wp\/v2\/tags?post=14569"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}