{"id":2965,"date":"2018-05-11T04:00:00","date_gmt":"2018-05-11T04:00:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/pma-ansokan-for-steen-solution-och-xps-inlamnad-till-fda\/"},"modified":"2018-05-11T04:00:00","modified_gmt":"2018-05-11T04:00:00","slug":"pma-ansokan-for-steen-solution-och-xps-inlamnad-till-fda","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/pma-ansokan-for-steen-solution-och-xps-inlamnad-till-fda\/","title":{"rendered":"PMA ans\u00f6kan f\u00f6r STEEN Solution\u2122 och XPS\u2122 inl\u00e4mnad till FDA"},"content":{"rendered":"
XVIVO Perfusion har l\u00e4mnat in PMA (Pre-market Approval) ans\u00f6kan f\u00f6r STEEN Solution\u2122 och XPS\u2122 till FDA. Den kliniska NOVEL-studien, d\u00e4r inkluderingen av alla patienter slutf\u00f6rdes i juni 2017, utg\u00f6r underlag f\u00f6r f\u00f6retagets PMA-ans\u00f6kan.<\/strong><\/div>\n

Lungtransplantation \u00e4r ett sista behandlingsalternativ f\u00f6r patienter med terminal lungsjukdom. Tyv\u00e4rr \u00e4r lungan en av de minst transplanterade organen, vilket g\u00f6r att m\u00e5nga patienter med terminal lungsjukdom d\u00f6r utan att bli transplanterade. \u00c5r 2016 blev 2 322 patienter lungtransplanterade i USA, 136 patienter avl\u00e4gsnades fr\u00e5n v\u00e4ntelistan eftersom de blev f\u00f6r sjuka f\u00f6r att genomg\u00e5 transplantation och 201 personer dog i v\u00e4ntan p\u00e5 en transplantation. Det uppskattas att mellan 37 och 45 procent av de initialt avvisade lungorna kan anv\u00e4ndas f\u00f6r transplantation.<\/span><\/p>\n

XPS\u2122 \u00e4r ett integrerat system som ger anv\u00e4ndaren flexibilitet att genomf\u00f6ra utv\u00e4rdering av lungor inf\u00f6r transplantation genom ett standardiserat och f\u00f6renklat f\u00f6rfarande. XPS\u2122-systemet med STEEN Solution\u2122 till\u00e5ter marginella lungor, som ursprungligen inte uppfyllde standardtransplantationskriterierna, att perfusioneras och ventileras vid normotermiska f\u00f6rh\u00e5llanden i upp till 4 timmar. Detta ger kirurger m\u00f6jlighet att ompr\u00f6va huruvida den marginella lungan kan transplanteras. XPS\u2122 och STEEN Solution\u2122 anv\u00e4nds \u00f6ver hela v\u00e4rlden med goda kliniska resultat. XPS\u2122 och STEEN Solution\u2122 har redan CE-m\u00e4rkts och \u00e4r d\u00e4rmed godk\u00e4nda f\u00f6r f\u00f6rs\u00e4ljning p\u00e5 den europeiska marknaden, samt \u00e4r ocks\u00e5 godk\u00e4nda f\u00f6r f\u00f6rs\u00e4ljning i Kanada och Australien.<\/span><\/p>\n

Inkluderingen av alla 220 (110 + 110) patienterna i NOVEL-studien som genomf\u00f6rs i USA med STEEN Solution\u2122 och XPS\u2122 \u00e4r slutf\u00f6rd. Denna kliniska studie kommer att utg\u00f6ra underlag f\u00f6r bolagets PMA (Pre-Market Approval) ans\u00f6kan hos FDA. Cirka 40 procent av alla lungtransplantationer i v\u00e4rlden utf\u00f6rs i USA och STEEN Solution\u2122 och XPS\u2122 \u00e4r redan tidigare godk\u00e4nt f\u00f6r f\u00f6rs\u00e4ljning i USA under ett s\u00e5 kallat HDE-godk\u00e4nnande (Humanitarian Device Exemption).<\/span><\/p>\n

I mars 2014 r\u00f6stade den r\u00e5dgivande panel som sammankallades av FDA enh\u00e4lligt med r\u00f6stsiffrorna 10-0, f\u00f6r att XPS\u2122 System med STEEN Solution\u2122 uppfyller kraven f\u00f6r HDE-godk\u00e4nnande (Humanitarian Device Exemption) genom att bevisa s\u00e4kerhet. I augusti 2014 fick XVIVO Perfusion HDE-godk\u00e4nnande fr\u00e5n FDA f\u00f6r XPS\u2122 med STEEN Solution\u2122 f\u00f6r normotermisk maskin-perfusion av initialt ej accepterade lungor. HDE-godk\u00e4nnande inneb\u00e4r vissa begr\u00e4nsningar, bland annat att h\u00f6gst 8 000 patienter f\u00e5r behandlas per \u00e5r under HDE-godk\u00e4nnande och att separata etiska tillst\u00e5nd kr\u00e4vs f\u00f6r behandling. Ett PMA godk\u00e4nnande skulle inneb\u00e4ra att s\u00e5dana restriktioner upph\u00f6r.<\/span><\/p>\n

NOVEL-studien som avslutade patientrekryteringen i juni 2017 forts\u00e4tter med uppf\u00f6ljning av patienterna i upp till ett \u00e5r. PAS (Post Approval Study), som \u00e4r en obligatorisk s\u00e4kerhetsuppf\u00f6ljning som f\u00f6ljer p\u00e5 alla godk\u00e4nnanden, inkluderade totalt 126+126 patienter och patientrekrytering var klar i slutet av 2017. Dessa patienter kommer f\u00f6ljas upp i tre \u00e5r. <\/span><\/p>\n

\u201dInl\u00e4mnandet av PMA-ans\u00f6kan var m\u00e5let f\u00f6r en sex\u00e5rig insats med f\u00f6retagets st\u00f6rsta multicenterstudie som n\u00e5gonsin utf\u00f6rts p\u00e5 v\u00e4rldens st\u00f6rsta marknad och \u00e4r d\u00e4rf\u00f6r en viktig milstolpe f\u00f6r f\u00f6retaget\u201d, s\u00e4ger Magnus Nilsson, VD f\u00f6r XVIVO Perfusion.<\/span><\/p>\n

G\u00f6teborg den 11 maj 2018
Magnus Nilsson, VD
<\/span>XVIVO Perfusion AB (publ)<\/p>\n

\n

F\u00f6r ytterligare information, v\u00e4nligen kontakta: <\/span><\/p>\n

Christoffer Rosenblad, CFO, +46 735 192159, christoffer.rosenblad@xvivoperfusion.com
Magnus Nilsson, VD, +46 31-788 21 50, magnus.nilsson@xvivoperfusion.com<\/span><\/p>\n

F\u00f6r ytterligare information om XVIVO Perfusions verksamhet h\u00e4nvisas till bolagets hemsida, www.xvivoperfusion.com<\/span><\/p>\n

Denna information \u00e4r s\u00e5dan information som Xvivo Perfusion AB (publ) \u00e4r skyldigt att offentligg\u00f6ra enligt EU:s marknadsmissbruksf\u00f6rordning. Informationen l\u00e4mnades, genom ovanst\u00e5ende kontaktpersons f\u00f6rsorg, f\u00f6r offentligg\u00f6rande klockan 6:00 den 11 maj 2018.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

XVIVO Perfusion har l\u00e4mnat in PMA (Pre-market Approval) ans\u00f6kan f\u00f6r STEEN Solution\u2122 och XPS\u2122 till FDA. Den kliniska NOVEL-studien, d\u00e4r…<\/p>\n","protected":false},"template":"","class_list":["post-2965","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-lang-sv","mfn-news-tag-mfn-regulatory","mfn-news-tag-mfn-regulatory-mar","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-ci-other"],"acf":[],"yoast_head":"\nPMA ans\u00f6kan f\u00f6r STEEN Solution\u2122 och XPS\u2122 inl\u00e4mnad till FDA - XVIVO<\/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.xvivogroup.com\/us\/pressreleases\/pma-ansokan-for-steen-solution-och-xps-inlamnad-till-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PMA ans\u00f6kan f\u00f6r STEEN Solution\u2122 och XPS\u2122 inl\u00e4mnad till FDA - XVIVO\" \/>\n<meta property=\"og:description\" content=\"XVIVO Perfusion har l\u00e4mnat in PMA (Pre-market Approval) ans\u00f6kan f\u00f6r STEEN Solution\u2122 och XPS\u2122 till FDA. 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