{"id":2660,"date":"2023-05-15T05:30:00","date_gmt":"2023-05-15T05:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/xvivos-ide-ansokan-for-sin-innovativa-hjartpreservationsteknologi-har-godkants-av-amerikanska-fda\/"},"modified":"2023-05-15T05:30:00","modified_gmt":"2023-05-15T05:30:00","slug":"xvivos-ide-ansokan-for-sin-innovativa-hjartpreservationsteknologi-har-godkants-av-amerikanska-fda","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/xvivos-ide-ansokan-for-sin-innovativa-hjartpreservationsteknologi-har-godkants-av-amerikanska-fda\/","title":{"rendered":"XVIVOs IDE-ans\u00f6kan f\u00f6r sin innovativa hj\u00e4rtpreservationsteknologi har godk\u00e4nts av amerikanska FDA"},"content":{"rendered":"
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The US Food & Drug Administration (FDA) har godk\u00e4nt XVIVOs Investigational Device Exemption (IDE) ans\u00f6kan f\u00f6r sin hj\u00e4rtpreservationsteknologi. Godk\u00e4nnandet till\u00e5ter XVIVO att starta "PRESERVE Clinical Trial: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors".<\/strong><\/p>\n<\/div>\n

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USA \u00e4r v\u00e4rldens st\u00f6rsta hj\u00e4rttransplantationsmarknad med ungef\u00e4r 4 100 hj\u00e4rttransplantationer genomf\u00f6rda under 2022. Med ett \u00f6kande antal patienter i behov av en transplantation s\u00e5 \u00e4r f\u00f6rm\u00e5gan att s\u00e4kert kunna anv\u00e4nda, bevara och transportera donerade organ kritiskt f\u00f6r att adressera den v\u00e4xande bristen p\u00e5 organ. 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. 2022 uppm\u00e4rksammades XVIVOs hj\u00e4rtpreservationsteknologi i globala nyhetsmedier som en avg\u00f6rande faktor vid den f\u00f6rsta framg\u00e5ngsrika xeno-hj\u00e4rttransplantationen (gris till m\u00e4nniska) som utf\u00f6rdes av University of Maryland i USA.<\/p>\n

Multicenterstudien PRESERVE avser utv\u00e4rdera s\u00e4kerhets- och effektivitetsdata som ska anv\u00e4ndas till st\u00f6d f\u00f6r ett Pre-Market Approval (PMA). Studien kommer att omfatta 141 patienter och involvera 15 amerikanska ledande transplantationscentra. Bland inklusionskriterierna finns inklusion av hj\u00e4rtan fr\u00e5n \u00e4ldre donatorer (definierade som 50 \u00e5r eller \u00e4ldre) samt hj\u00e4rtan fr\u00e5n l\u00e5ngdistansdonatorer. Genom att inkludera l\u00e5ngdistansdonatorer \u00e4r XVIVOs m\u00e5l att vidare demonstrera de resultat som presenterades vid ISHLT[1]<\/a> i april 2023 fr\u00e5n den pr\u00f6varinitierade NIHP[2]<\/a>-studien i Australien och Nya Zeeland \u2013 att syresatt perfusion av donatorhj\u00e4rtan med hj\u00e4lp av XVIVOs innovativa teknik kan m\u00f6jligg\u00f6ra kompromissl\u00f6s organkvalitet efter preservation trots avsev\u00e4rt f\u00f6rl\u00e4ngda transporttider.<\/p>\n

\u201dJag skulle vilja uttrycka min enorma uppskattning till teamet p\u00e5 XVIVO, PRESERVE Trial-utredarna och FDA f\u00f6r deras insats och anstr\u00e4ngningar f\u00f6r att s\u00e4kerst\u00e4lla att studien kommer att genomf\u00f6ras med h\u00f6g trov\u00e4rdighet och tillgodose det mest akuta behovet f\u00f6r patienter och teamen som utf\u00f6r transplantationerna, s\u00e4ger Jaya Tiwari, Vice President Clinical & Regulatory Affairs, USA, XVIVO. "Vi \u00e4r glada \u00f6ver entusiasmen hos v\u00e5ra ledande hj\u00e4rttransplantationscenter inf\u00f6r att vara en del av denna studie. Vi f\u00f6rv\u00e4ntar oss att den f\u00f6rsta patienten i USA kommer att inkluderas under sensommaren. Detta sker parallellt med att vi f\u00f6rbereder oss f\u00f6r inkluderingen av den sista patienten i den europeiska hj\u00e4rtpreservationsstudien.\u201d<\/p>\n

\u201dJag \u00e4r glad att vi nu erh\u00e5llit tillst\u00e5nd att starta v\u00e5r amerikanska hj\u00e4rtpreservationsstudie. Tekniken har potential att f\u00f6r\u00e4ndra paradigmet inom hj\u00e4rttransplantation och anv\u00e4nds idag redan vid ca 25 procent av alla hj\u00e4rttransplantationer i Australien och Nya Zeeland genom s\u00e4rskilt myndighetstillst\u00e5nd i v\u00e4ntan p\u00e5 regulatoriskt godk\u00e4nnande. V\u00e5r vision \u00e4r att ingen ska d\u00f6 i v\u00e4ntan p\u00e5 ett nytt organ, och d\u00e4rf\u00f6r g\u00f6r det mig v\u00e4ldigt glad att vi nu genom den amerikanska studien kan introducera teknologin p\u00e5 v\u00e4rldens st\u00f6rsta hj\u00e4rttransplantationsmarknad\u201d, s\u00e4ger Christoffer Rosenblad, VD XVIVO.<\/p>\n\n

[1]<\/a> ISHLT \u2013 International Society of Lung and Heart Transplantation
[2]<\/a> NIHP \u2013 Non-ischemic Heart Preservation<\/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

XVIVOs IDE-ans\u00f6kan f\u00f6r sin innovativa hj\u00e4rtpreservationsteknologi har godk\u00e4nts av amerikanska FDA<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The US Food & Drug Administration (FDA) har godk\u00e4nt XVIVOs Investigational Device Exemption (IDE) ans\u00f6kan f\u00f6r sin hj\u00e4rtpreservationsteknologi. Godk\u00e4nnandet till\u00e5ter…<\/p>\n","protected":false},"template":"","class_list":["post-2660","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":"\nXVIVOs IDE-ans\u00f6kan f\u00f6r sin innovativa hj\u00e4rtpreservationsteknologi har godk\u00e4nts av 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\/xvivos-ide-ansokan-for-sin-innovativa-hjartpreservationsteknologi-har-godkants-av-amerikanska-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"XVIVOs IDE-ans\u00f6kan f\u00f6r sin innovativa hj\u00e4rtpreservationsteknologi har godk\u00e4nts av amerikanska FDA - XVIVO\" \/>\n<meta property=\"og:description\" content=\"The US Food & Drug Administration (FDA) har godk\u00e4nt XVIVOs Investigational Device Exemption (IDE) ans\u00f6kan f\u00f6r sin hj\u00e4rtpreservationsteknologi. 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