{"id":6597,"date":"2024-04-11T08:10:00","date_gmt":"2024-04-11T08:10:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/resultat-presenterade-fran-xvivos-kliniska-studie-for-hjartpreservation-nihp2019-pa-ishlt-i-prag\/"},"modified":"2024-04-11T13:14:25","modified_gmt":"2024-04-11T13:14:25","slug":"resultat-presenterade-fran-xvivos-kliniska-studie-for-hjartpreservation-nihp2019-pa-ishlt-i-prag","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/resultat-presenterade-fran-xvivos-kliniska-studie-for-hjartpreservation-nihp2019-pa-ishlt-i-prag\/","title":{"rendered":"Resultat presenterade fr\u00e5n XVIVOs kliniska studie f\u00f6r hj\u00e4rtpreservation NIHP2019 p\u00e5 ISHLT i Prag"},"content":{"rendered":"<div class=\"mfn-preamble\">\n<p><strong>P\u00e5 kongressen International Society of Heart and Lung Transplantation 2024 (ISHLT) i Prag, Tjeckien, presenterades idag resultaten fr\u00e5n XVIVOs kliniska studie, NIHP2019, inom hj\u00e4rttransplantation.<\/strong><\/p>\n<\/div>\n<div class=\"mfn-body\">\n<p>Resultaten av den prim\u00e4ra analysen, som unders\u00f6ker allvarliga komplikationer efter hj\u00e4rttransplantation, visar att dessa intr\u00e4ffade hos 18,8 % av patienter som erh\u00f6ll ett donerat hj\u00e4rta bevarat med XVIVO Heart Assist Transport. Hos kontrollgruppen, som erh\u00f6ll ett hj\u00e4rta transporterat p\u00e5 is, den nuvarande standardmetoden f\u00f6r hj\u00e4rtpreservation, drabbades d\u00e4remot 30,1 % av patienterna av motsvarande komplikationer.<\/p>\n<p>Frekvensen av allvarlig prim\u00e4r hj\u00e4rtdysfunktion efter transplantation (PGD) var ocks\u00e5 betydligt l\u00e4gre hos patienter som fick ett donerat hj\u00e4rta bevarat med XVIVO Heart Assist Transport (11 % j\u00e4mf\u00f6rt med 28 % f\u00f6r kontrollgruppen).<\/p>\n<p>&#34;Denna studie demonstrerar en betydande f\u00f6rb\u00e4ttring f\u00f6r bevarande av donerade hj\u00e4rtan,&#34; s\u00e4ger Filip Rega, professor i hj\u00e4rtkirurgi och transplantation vid universitetssjukhusen i Leuven, Belgien, samordnande pr\u00f6vare f\u00f6r studien. &#34;Prim\u00e4r hj\u00e4rtdysfunktion \u00e4r en fruktad komplikation efter en hj\u00e4rttransplantation kopplad till allvarlig sjuklighet och d\u00f6dlighet. Resultaten fr\u00e5n studien p\u00e5visar en viktig och kliniskt relevant minskning av prim\u00e4r hj\u00e4rtdysfunktion f\u00f6r de patienter som transplanterades med ett donerat hj\u00e4rta bevarat med denna nya teknologi.&#34;<\/p>\n<p>&#34;NIHP2019-studien \u00e4r resultatet av m\u00e5nga \u00e5rs h\u00e5rt arbete och samarbete, och utg\u00f6r en av de st\u00f6rsta bedrifterna i XVIVOs historia. Den tar oss \u00e4ven ett steg n\u00e4rmare v\u00e5r vision att ingen ska d\u00f6 i v\u00e4ntan p\u00e5 ett nytt organ. F\u00f6r n\u00e4rvarande anv\u00e4nds endast 30 procent av tillg\u00e4ngliga donerade hj\u00e4rtan f\u00f6r transplantation och detta m\u00e5ste f\u00f6r\u00e4ndras. Som ett forskningsdrivet och innovativt f\u00f6retag \u00e4r v\u00e5r hj\u00e4rtteknologi ett bevis p\u00e5 att XVIVO \u00e4r dedikerade till att f\u00f6r\u00e4ndra paradigmet inom hj\u00e4rtpreservation,&#34; s\u00e4ger Christoffer Rosenblad, VD f\u00f6r XVIVO.<br \/>\u00a0<br \/>Den kliniska studien NIHP2019 \u00e4r en randomiserad, kontrollerad, \u00f6ppen, multicenter klinisk pr\u00f6vning av XVIVO Heart Assist Transport som syftar till att samla in data om s\u00e4kerhet och effektivitet som skall anv\u00e4ndas som underlag f\u00f6r en CE-m\u00e4rkning. Inom studien NIHP2019 har 203 patienter inkluderats fr\u00e5n 15 transplantationskliniker i 8 europeiska l\u00e4nder mellan november 2020 och maj 2023.<\/p>\n<p>I USA har XVIVO erh\u00e5llit ett Investigational Device Exemption (IDE) godk\u00e4nnande av FDA f\u00f6r en studie f\u00f6r hj\u00e4rtpreservation (PRESERVE) f\u00f6r att samla in data om s\u00e4kerhet och effektivitet som kr\u00e4vs f\u00f6r att st\u00f6dja en framtida PMA-ans\u00f6kning. Inklusion av patienter i PRESERVE-studien \u00e4r p\u00e5g\u00e5ende.<br \/>\u00a0<br \/>11 april, 2024<br \/>G\u00f6teborg<br \/>Christoffer Rosenblad, VD<br \/>XVIVO Perfusion AB (publ)<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-fb9cf3b124f9\">\n<p><strong class=\"mfn-heading-1\">F\u00f6r ytterligare information, v\u00e4nligen kontakta:<\/strong><\/p>\n<hr\/>\n<p>Christoffer Rosenblad, VD, +46 73 519 21 59, e-post: christoffer.rosenblad@xvivogroup.com<br \/>Kristoffer\u00a0Nordstr\u00f6m,\u00a0CFO, +46 73 519 21 64, e-post:\u00a0kristoffer.nordstrom@xvivogroup.com<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-about mfn-da5f5ee9f867\">\n<p><strong class=\"mfn-heading-1\">Om oss<\/strong><\/p>\n<hr\/>\n<p>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<div class=\"mfn-footer mfn-regulatory mfn-regulatory-mar\">\n<p><em>Denna information \u00e4r s\u00e5dan information som XVIVO Perfusion AB \u00e4r skyldigt att offentligg\u00f6ra enligt EU:s marknadsmissbruksf\u00f6rordning. Informationen l\u00e4mnades, genom ovanst\u00e5ende kontaktpersoners f\u00f6rsorg, f\u00f6r offentligg\u00f6rande den 2024-04-11 10:10 CEST.<\/em><\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Bifogade filer<\/strong><\/p>\n<hr\/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/ea4153e2-3849-4def-b487-9850beb4ab29\/resultat-presenterade-fran-xvivos-kliniska-studie-for-hjartpreservation-nihp2019-pa-ishlt-i-prag.pdf\" rel=\"noopener\" target=\"_blank\">Resultat presenterade fr\u00e5n XVIVOs kliniska studie f\u00f6r hj\u00e4rtpreservation NIHP2019 p\u00e5 ISHLT i Prag<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>P\u00e5 kongressen International Society of Heart and Lung Transplantation 2024 (ISHLT) i Prag, Tjeckien, presenterades idag resultaten fr\u00e5n XVIVOs kliniska&#8230;<\/p>\n","protected":false},"template":"","class_list":["post-6597","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":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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