{"id":2718,"date":"2022-04-27T08:30:00","date_gmt":"2022-04-27T08:30:00","guid":{"rendered":"https:\/\/www.xvivogroup.com\/us\/mfn_news\/xvivo-lamnar-in-en-ide-ansokan-till-amerikanska-fda-for-sin-innovativa-hjartteknologi-en-betydande-milstolpe\/"},"modified":"2022-04-27T08:30:00","modified_gmt":"2022-04-27T08:30:00","slug":"xvivo-lamnar-in-en-ide-ansokan-till-amerikanska-fda-for-sin-innovativa-hjartteknologi-en-betydande-milstolpe","status":"publish","type":"mfn_news","link":"https:\/\/www.xvivogroup.com\/us\/pressreleases\/xvivo-lamnar-in-en-ide-ansokan-till-amerikanska-fda-for-sin-innovativa-hjartteknologi-en-betydande-milstolpe\/","title":{"rendered":"XVIVO l\u00e4mnar in en IDE-ans\u00f6kan till amerikanska FDA f\u00f6r sin innovativa hj\u00e4rtteknologi \u2013 en betydande milstolpe"},"content":{"rendered":"
\n

XVIVO tillk\u00e4nnager stolt att en Investigational Device Exemption (IDE) ans\u00f6kan l\u00e4mnats in till US Food & Drug Administration (FDA). Ans\u00f6kan kommer att st\u00f6dja ett initialt regulatoriskt godk\u00e4nnande fr\u00e5n FDA f\u00f6r att genomf\u00f6ra den kliniska studien: "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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Ans\u00f6kan g\u00f6rs i f\u00f6rening med FDAs tidigare Breakthrough Designation godk\u00e4nnande som gavs till XVIVOs hj\u00e4rtteknologi f\u00f6r maskinperfusion som \u00e4r en s\u00e5 kallad Non-Ischemic Heart Preservation (NIHP) teknologi. XVIVO har i f\u00f6rberedande m\u00f6ten med FDA diskuterat fr\u00e5gor och problemst\u00e4llningar, och har anv\u00e4nt FDAs respons f\u00f6r att best\u00e4mma r\u00e4tt inriktning p\u00e5 sin IDE-ans\u00f6kan. En IDE godk\u00e4nner att teknologin som skall utv\u00e4rderas anv\u00e4nds i en klinisk studie i syfte att samla in data avseende s\u00e4kerhet och effektivitet. XVIVO kommer att anv\u00e4nda insamlad data som underlag f\u00f6r en Pre-Market Approval (PMA)-ans\u00f6kan.<\/p>\n

2019 fanns det 112 000 patienter p\u00e5 den amerikanska v\u00e4ntelistan f\u00f6r en transplantation samtidigt som enbart 39 718 transplantationer utf\u00f6rdes. Med en \u00f6kande brist p\u00e5 donerade organ s\u00e5 v\u00e4xer behovet av att kunna bevara tillg\u00e4ngliga organ p\u00e5 ett effektivt s\u00e4tt. XVIVOs hj\u00e4rtteknologi \u00e4r utvecklad f\u00f6r att bevara donatorhj\u00e4rtan utanf\u00f6r kroppen med NIHP-teknologi, under transport, inf\u00f6r en transplantation.<\/p>\n

Teknologin uppfanns av professor Stig Steen vid Igel\u00f6sa Lifescience och har utvecklats i samarbete med XVIVO. Teknologin, perfusionsmaskin och l\u00f6sning, \u00e4r patenterade av XVIVO.<\/p>\n

"Vi \u00e4r mycket n\u00f6jda med planen f\u00f6r den kliniska pr\u00f6vningen som anges i IDE-ans\u00f6kan. Vi k\u00e4nner att den p\u00e5 ett korrekt s\u00e4tt \u00e5terger tankes\u00e4ttet i Breakthrough Designation godk\u00e4nnandet och ser fram emot FDAs respons" s\u00e4ger Jaya Tiwari, XVIVOs Vice President Clinical & Regulatory Affairs, USA. "Vi f\u00f6rv\u00e4ntar oss att v\u00e5ra diskussioner med FDA kommer att avslutas under f\u00f6rsta delen av 2022. M\u00e5let \u00e4r att b\u00f6rja inkludera patienter f\u00f6r studien under sommaren. Detta kommer att ske p\u00e5 flertalet ledande amerikanska sjukhus som redan har utryckt ett stort intresse f\u00f6r att delta i studien. Vi kommer kunna f\u00f6ra mer detaljerade diskussioner kring studien n\u00e4r vi v\u00e4l f\u00e5tt v\u00e5r IDE-ans\u00f6kan godk\u00e4nd."<\/p>\n

"Denna betydelsefulla milstolpe \u00e4r ytterligare ett bevis p\u00e5 v\u00e5rt fokus p\u00e5 att ingen skall beh\u00f6va d\u00f6 i v\u00e4ntan p\u00e5 ett nytt organ. USA \u00e4r v\u00e5r st\u00f6rsta marknad och d\u00e4rf\u00f6r kommer denna IDE-ans\u00f6kan f\u00f6r v\u00e5r hj\u00e4rtteknologi att vara en viktig ut\u00f6kning av de redan p\u00e5g\u00e5ende kliniska studierna i Europa, Australien och Nya Zeeland. Eftersom XVIVO \u00e4r ett forskningsdrivet f\u00f6retag \u00e4r det mycket tillfredsst\u00e4llande n\u00e4r h\u00e5rt arbete visar p\u00e5tagliga resultat\u201d, s\u00e4ger Dag Andersson, VD f\u00f6r XVIVO.
\u00a0
22 April, 2022
G\u00f6teborg
Dag Andersson, CEO
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@xvivogroup.com
Kristoffer\u00a0Nordstr\u00f6m,\u00a0CFO, +46 73-519 21 64,\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

XVIVO l\u00e4mnar in en IDE-ans\u00f6kan till amerikanska FDA f\u00f6r sin innovativa hj\u00e4rtteknologi \u2013 en betydande milstolpe<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

XVIVO tillk\u00e4nnager stolt att en Investigational Device Exemption (IDE) ans\u00f6kan l\u00e4mnats in till US Food & Drug Administration (FDA). 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