{"id":2787,"date":"2021-05-04T05:30:00","date_gmt":"2021-05-04T05:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/510k-ansokan-for-kidney-assist-transport-inlamnad-till-amerikanska-fda\/"},"modified":"2021-05-04T05:30:00","modified_gmt":"2021-05-04T05:30:00","slug":"510k-ansokan-for-kidney-assist-transport-inlamnad-till-amerikanska-fda","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/510k-ansokan-for-kidney-assist-transport-inlamnad-till-amerikanska-fda\/","title":{"rendered":"510(k)-ans\u00f6kan f\u00f6r Kidney Assist Transport inl\u00e4mnad till amerikanska FDA"},"content":{"rendered":"
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XVIVO har l\u00e4mnat in 510(k)-ans\u00f6kan f\u00f6r Kidney Assist Transport till FDA med m\u00e5ls\u00e4ttning att f\u00e5 produkten regulatoriskt godk\u00e4nd f\u00f6r f\u00f6rs\u00e4ljning p\u00e5 den amerikanska marknaden senare under 2021.<\/strong><\/p>\n<\/div>\n

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Efter tillk\u00e4nnagivandet av XVIVO\u2019s f\u00f6rv\u00e4rv av Organ Assist B.V. den 1 oktober 2020 \u00e4r 510(k) inl\u00e4mnande f\u00f6r Kidney Assist Transport en viktig milstolpe f\u00f6r XVIVO i strategin att etablera en kommersiell n\u00e4rvaro inom abdominal transplantation i USA.
\u00a0
Kidney Assist Transport \u00e4r XVIVO\u2019s transportabla system f\u00f6r preservation av njurar. Systemet m\u00f6jligg\u00f6r isolerad hypotermisk syresatt perfusion av donerade njurar under transport fr\u00e5n donator till mottagare i samband med njurtransplantation.<\/p>\n

Njursjukdomar \u00e4r enligt WHO v\u00e4rldens tionde fr\u00e4msta d\u00f6dsorsak. Patienter som lider av kronisk njursvikt beh\u00f6ver regelbunden dialys eller njurtransplantation f\u00f6r att \u00f6verleva. Transplantation \u00e4r oftast den b\u00e4sta behandlingen eftersom patienten slipper dialys, medicinering och frekventa l\u00e4karkontroller. Dialys \u00e4r dessutom en mycket kostsam livsuppr\u00e4tth\u00e5llande behandlingsform. Under 2019 utf\u00f6rdes cirka 62\u00a0000 njurtransplantationer fr\u00e5n avlidna donatorer i v\u00e4rlden. USA \u00e4r idag den \u00f6verl\u00e4gset st\u00f6rsta marknaden med cirka 17\u00a0500 njurtransplantationer fr\u00e5n avlidna donatorer under 2019. Antalet patienter p\u00e5 v\u00e4ntelistan i USA \u00f6verstiger 90\u00a0000, s\u00e5 behovet av organ tillg\u00e4ngliga f\u00f6r transplantation \u00f6verstiger vida utbudet.
\u00a0
\u201dInl\u00e4mnandet av 510(k)-ans\u00f6kan \u00e4r en viktig milstolpe f\u00f6r XVIVO. Kidney Assist Transport-maskinen \u00e4r en unik produkt med potential att transformera hela marknaden inom njurtransplantation genom att f\u00f6rl\u00e4nga livet f\u00f6r njurar och f\u00e5 fler njurar tillg\u00e4ngliga f\u00f6r transplantation. I december publicerades en studie i den ansedda vetenskapliga tidskriften the Lancet d\u00e4r de enast\u00e5ende kliniska f\u00f6rdelarna med Kidney Assist Transport och dess syresatta perfusion av njurar tydligt demonstrerades. Det \u00e4r d\u00e4rmed med stor entusiasm vi nu ser fram emot att, givet att regulatoriskt godk\u00e4nnande erh\u00e5lls, kunna lansera produkten p\u00e5 den amerikanska marknaden\u201d, s\u00e4ger Dag Andersson, VD f\u00f6r XVIVO.
\u00a0
G\u00f6teborg,\u00a04\u00a0Maj 2021
Dag Andersson, VD
XVIVO Perfusion AB (publ) <\/p>\n<\/div>\n

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

Dag Andersson, VD, +46 31-788 21 50,\u00a0dag.andersson@xvivoperfusion.com<\/a>
Kristoffer\u00a0Nordstr\u00f6m,\u00a0CFO, +46 73-519 21 64,\u00a0kristoffer.nordstrom@xvivoperfusion.com<\/a><\/p>\n<\/div>\n

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Om oss<\/strong><\/p>\n\n

XVIVO grundades 1998 och \u00e4r ett medicintekniskt f\u00f6retag dedikerat till att f\u00f6rl\u00e4nga livet f\u00f6r donerade organ s\u00e5 att transplantationsteam runt om i v\u00e4rlden kan r\u00e4dda fler liv. V\u00e5ra l\u00f6sningar g\u00f6r det m\u00f6jligt f\u00f6r ledande kliniker och forskare att t\u00e4nja p\u00e5 gr\u00e4nserna f\u00f6r transplantationsmedicin.\u00a0XVIVO har sitt huvudkontor i G\u00f6teborg och har kontor och forskningsanl\u00e4ggningar p\u00e5 tv\u00e5 kontinenter. Bolaget \u00e4r noterat p\u00e5 Nasdaq Stockholm\u00a0och handlas under symbolen XVIVO. Mer information finns att l\u00e4sa p\u00e5 hemsidan www.xvivoperfusion.com.<\/a><\/p>\n<\/div>\n

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Bifogade filer<\/strong><\/p>\n\n

510(k)-ans\u00f6kan f\u00f6r Kidney Assist Transport inl\u00e4mnad till amerikanska FDA<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

XVIVO har l\u00e4mnat in 510(k)-ans\u00f6kan f\u00f6r Kidney Assist Transport till FDA med m\u00e5ls\u00e4ttning att f\u00e5 produkten regulatoriskt godk\u00e4nd f\u00f6r f\u00f6rs\u00e4ljning…<\/p>\n","protected":false},"template":"","class_list":["post-2787","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-lang-sv","mfn-news-tag-mfn-ci","mfn-news-tag-mfn-ci-other","mfn-news-tag-mfn","mfn-news-tag-mfn-type-ir"],"acf":[],"yoast_head":"\n510(k)-ans\u00f6kan f\u00f6r Kidney Assist Transport inl\u00e4mnad till amerikanska 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\/510k-ansokan-for-kidney-assist-transport-inlamnad-till-amerikanska-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"510(k)-ans\u00f6kan f\u00f6r Kidney Assist Transport inl\u00e4mnad till amerikanska FDA - 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