{"id":2658,"date":"2023-05-23T13:00:00","date_gmt":"2023-05-23T13:00:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/inklusion-av-patienter-avslutad-i-xvivos-europeiska-kliniska-studie-for-hjartpreservation\/"},"modified":"2023-05-23T13:00:00","modified_gmt":"2023-05-23T13:00:00","slug":"inklusion-av-patienter-avslutad-i-xvivos-europeiska-kliniska-studie-for-hjartpreservation","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/inklusion-av-patienter-avslutad-i-xvivos-europeiska-kliniska-studie-for-hjartpreservation\/","title":{"rendered":"Inklusion av patienter avslutad i XVIVOs europeiska kliniska studie f\u00f6r hj\u00e4rtpreservation"},"content":{"rendered":"
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XVIVOs innovativa hj\u00e4rtteknologi \u00e4r f\u00f6r n\u00e4rvarande under pr\u00f6vning i en randomiserad kontrollerad klinisk studie omfattande 15 ledande transplantationscenter i 8 europeiska l\u00e4nder. 202 patienter har nu genomg\u00e5tt en transplantation inom studien, vilket inneb\u00e4r att inkluderingen nu \u00e4r klar av alla planerade patienter. N\u00e4sta steg \u00e4r en ett\u00e5rig uppf\u00f6ljningsfas d\u00e4r resultaten kommer att samlas in och analyseras innan studien avslutas och slutresultaten presenteras. Arbetet med processen inf\u00f6r ett produktgodk\u00e4nnande har redan p\u00e5b\u00f6rjats och givet att ans\u00f6kan uppfyller kraven enligt MDR (Medical Device Regulation) kan en CE-m\u00e4rkning f\u00f6rv\u00e4ntas under f\u00f6rsta halvan av 2024.<\/strong><\/p>\n<\/div>\n

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XVIVOs hj\u00e4rtpreservationsteknologi \u00e4r utvecklad f\u00f6r att bevara donatorhj\u00e4rtan utanf\u00f6r kroppen under transport med hj\u00e4lp av kall, syresatt perfusion. Teknologin, perfusionsmaskin och l\u00f6sning, \u00e4r utvecklad tillsammans med professor Stig Steen vid Igel\u00f6sa Lifescience och \u00e4r patenterad.<\/p>\n

Den europeiska multicenterstudien \u00e4r XVIVOs f\u00f6rsta studie f\u00f6r hj\u00e4rtpreservation. En amerikansk klinisk multicenterstudie f\u00f6rv\u00e4ntas starta i slutet av september.<\/p>\n

"Vi \u00e4r tacksamma f\u00f6r den support vi f\u00e5tt fr\u00e5n patienter och kliniska pr\u00f6vare som valt att delta i denna europeiska kliniska studie. Vi \u00e4r stolta \u00f6ver att vi har f\u00e5tt ett s\u00e5 stort intresse och engagemang fr\u00e5n ledande hj\u00e4rttransplantationscenter i hela Europa. Kirurger som \u00e4r involverade i studien har uttryckt sin entusiasm f\u00f6r teknologin, och nu v\u00e4ntar de ot\u00e5ligt p\u00e5 att all data skall analyseras och presenteras\u201d, s\u00e4ger Andreas Wallinder, Chief Medical Officer p\u00e5 XVIVO. "De positiva initiala resultaten som nyligen presenterades fr\u00e5n den australiensiska\/nyazeel\u00e4ndska studien st\u00e4rker oss i v\u00e5rt arbete med att f\u00f6rb\u00e4ttra patienters f\u00f6ruts\u00e4ttningar efter en transplantation n\u00e4r man anv\u00e4nt v\u00e5r unika hj\u00e4rtteknologi."<\/p>\n

\u201dAtt h\u00f6ra ledande transplantationskirurgers positiva vittnesm\u00e5l om en direkt, p\u00e5taglig skillnad f\u00f6r patienter efter att XVIVOs hj\u00e4rtteknologi har anv\u00e4nds g\u00f6r oss f\u00f6rv\u00e4ntansfulla och medf\u00f6r att vi g\u00e5r st\u00e4rkta in i ans\u00f6kningsprocessen f\u00f6r regulatoriskt godk\u00e4nnande inf\u00f6r kommersialisering. Vi tror att den nya innovativa hj\u00e4rtteknologin fr\u00e5n XVIVO har potential att f\u00f6r\u00e4ndra paradigmet inom bevarade av hj\u00e4rtan, vilket kommer att leda till att man anv\u00e4nder fler tillg\u00e4ngliga hj\u00e4rtan som i sin tur r\u00e4dda fler liv\u201d, s\u00e4ger Christoffer Rosenblad, XVIVO VD.<\/p>\n

23 maj, 2023
G\u00f6teborg
Christoffer Rosenblad, XVIVO CEO
XVIVO Perfusion AB (publ)<\/p>\n<\/div>\n

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

Christoffer Rosenblad, VD, +46 73 519 21 59, e-post: christoffer.rosenblad@xvivogroup.com
Kristoffer\u00a0Nordstr\u00f6m,\u00a0CFO, +46 73 519 21 64, e-post:\u00a0kristoffer.nordstrom@xvivogroup.com<\/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.xvivogroup.com\/us<\/p>\n<\/div>\n

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

Inklusion av patienter avslutad i XVIVOs europeiska kliniska studie f\u00f6r hj\u00e4rtpreservation<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

XVIVOs innovativa hj\u00e4rtteknologi \u00e4r f\u00f6r n\u00e4rvarande under pr\u00f6vning i en randomiserad kontrollerad klinisk studie omfattande 15 ledande transplantationscenter i 8…<\/p>\n","protected":false},"template":"","class_list":["post-2658","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-ci","mfn-news-tag-mfn-ci-other"],"acf":[],"yoast_head":"\nInklusion av patienter avslutad i XVIVOs europeiska kliniska studie f\u00f6r hj\u00e4rtpreservation - 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\/inklusion-av-patienter-avslutad-i-xvivos-europeiska-kliniska-studie-for-hjartpreservation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Inklusion av patienter avslutad i XVIVOs europeiska kliniska studie f\u00f6r hj\u00e4rtpreservation - 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