{"id":3098,"date":"2016-01-07T07:30:00","date_gmt":"2016-01-07T07:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/primecc-har-erhallit-ce-marke\/"},"modified":"2016-01-07T07:30:00","modified_gmt":"2016-01-07T07:30:00","slug":"primecc-har-erhallit-ce-marke","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/primecc-har-erhallit-ce-marke\/","title":{"rendered":"PrimECC har erh\u00e5llit CE-m\u00e4rke"},"content":{"rendered":"<div class=\"mfn-preamble\"><strong>XVIVO Perfusion har erh\u00e5llit CE-m\u00e4rke p\u00e5 en patentskyddad produkt, PrimECC<sup>\u00ae<\/sup>, utvecklad f\u00f6r att f\u00f6rbereda (priming p\u00e5 engelska) hj\u00e4rtlungmaskinen inf\u00f6r \u00f6ppen hj\u00e4rtkirurgi. F\u00f6retaget kommer att ut\u00f6ka den kliniska dokumentationen f\u00f6r PrimECC<sup>\u00ae<\/sup> genom fler kliniska studier under 2016.<\/strong><\/div>\n<p><span>PrimECC<strong><sup>\u00ae<\/sup><\/strong> \u00e4r en v\u00e4tska som utvecklats i samarbete med Professor Stig Steen i Lund, f\u00f6r att f\u00f6rbereda hj\u00e4rtlungmaskiner f\u00f6re anv\u00e4ndning. Dessa maskiner anv\u00e4nds f\u00f6r att driva blodcirkulationen och ta \u00f6ver syres\u00e4ttningen av blodet ist\u00e4llet f\u00f6r hj\u00e4rta och lungor under hj\u00e4rtoperationer. V\u00e4tskan \u00e4r till f\u00f6r att undvika att luftbubblor kommer in i patientens cirkulation n\u00e4r hj\u00e4rtlungmaskinen startas, samt f\u00f6r att kompensera f\u00f6r den blodvolym som under operationen finns utanf\u00f6r patienten, i hj\u00e4rtlungmaskinen. Idag anv\u00e4nds som regel enkla saltl\u00f6sningar f\u00f6r detta \u00e4ndam\u00e5l. Syftet med PrimECC<sup>\u00ae<\/sup> \u00e4r att minimera biverkningar som kan uppst\u00e5 vid och efter anv\u00e4ndning av hj\u00e4rtlungmaskin. <\/span><\/p>\n<p><span>En \u2019proof of concept\u2019 studie som gjorts med PrimECC<sup>\u00ae<\/sup> visar intressanta kliniska resultat. F\u00f6r att ut\u00f6ka dokumentationen kommer f\u00f6retaget under 2016 att genomf\u00f6ra en randomiserad klinisk studie p\u00e5 80 patienter vid Sahlgrenska Universitetssjukhuset i G\u00f6teborg. XVIVO planerar inte n\u00e5gon omfattande lansering av produkten innan denna studie \u00e4r slutf\u00f6rd. XVIVO Perfusion har ans\u00f6kt om patent f\u00f6r PrimECC<sup>\u00ae<\/sup> p\u00e5 viktiga marknader och har hittills beviljats patent i USA och EU. <\/span><\/p>\n<p><span>\u201dDet sker flera hundratusen hj\u00e4rtoperationer per \u00e5r i v\u00e4rlden d\u00e5 hj\u00e4rtlungmaskin anv\u00e4nds och den \u2019proof of concept\u2019 studie som gjorts med PrimECC<sup>\u00ae<\/sup> indikerar att patienten f\u00e5r f\u00f6rb\u00e4ttrad v\u00e4tskebalans efter operationen om hj\u00e4rtlungmaskinen preparerats med PrimECC<sup>\u00ae<\/sup>, ist\u00e4llet f\u00f6r med de enklare l\u00f6sningar som ofta anv\u00e4nds. Arbete med att bredda den kliniska dokumentationen p\u00e5g\u00e5r d\u00e5 produkten har en intressant klinisk och kommersiell potential\u201d s\u00e4ger XVIVO Perfusions VD Magnus Nilsson. <\/span><\/p>\n<\/p>\n<p><span>G\u00f6teborg 7 januari 2016<br \/>XVIVO Perfusion AB (publ)<\/span><\/p>\n<div class=\"mfn-footer\">\n<p><span>F\u00f6r ytterligare information, v\u00e4nligen kontakta: <\/span><\/p>\n<p><span>Christoffer Rosenblad, CFO, tel: 031-788 21 59 alternativt +1\u00a0720\u00a0616 2101, e-post: <a href=\"mailto:christoffer.rosenblad@xvivperfusion.com\" rel=\"nofollow\">christoffer.rosenblad@xvivoperfusion.com<\/a><br \/>F\u00f6r ytterligare information om XVIVO Perfusions verksamhet h\u00e4nvisas till bolagets hemsida, <a href=\"http:\/\/www.xvivoperfusion.com\" rel=\"nofollow\">www.xvivoperfusion.com<\/a><\/span><\/p>\n<p><span>Informationen l\u00e4mnades f\u00f6r publicering den 7 januari 2016 kl. 08:30.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>XVIVO Perfusion har erh\u00e5llit CE-m\u00e4rke p\u00e5 en patentskyddad produkt, PrimECC\u00ae, utvecklad f\u00f6r att f\u00f6rbereda (priming p\u00e5 engelska) hj\u00e4rtlungmaskinen inf\u00f6r \u00f6ppen&#8230;<\/p>\n","protected":false},"template":"","class_list":["post-3098","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci-other","mfn-news-tag-mfn","mfn-news-tag-mfn-type-ir","mfn-news-tag-mfn-lang-sv","mfn-news-tag-mfn-ci"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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