Nā Microspheres Embolic Polyvinyl Alcohol Elastic Design ʻAʻole hiki ke palaho
Ua manaʻo ʻia nā Embolic Microspheres e hoʻohana ʻia no ka embolization o nā arteriovenous malformations (AVMs) a me nā puʻupuʻu hypervascular, me nā fibroids uterine.
Inoa maʻamau a maʻamau paha: Polyvinyl Alcohol Embolic Microspheres
Inoa Hoʻokaʻawale: Mea Hana Embolization Vascular
Hoʻokaʻawale ʻana: Papa II
Panel: Cardiovascular
ʻO nā Embolic Microspheres he mau microspheres hydrogel hiki ke hoʻopili ʻia me ke ʻano maʻamau, ka ʻili laumania, a me ka nui i hoʻoponopono ʻia, i hana ʻia ma muli o ka hoʻololi kemika ma nā mea polyvinyl alcohol (PVA). Aia nā Embolic Microspheres i kahi macromer i loaʻa mai ka polyvinyl alcohol (PVA), a he hydrophilic, non-resorbable, a loaʻa i nā ʻano nui like ʻole. ʻO ka hopena mālama he 0.9% sodium chloride solution. ʻO ka nui o ka wai o ka microsphere polymerized piha he 91% ~ 94%. Hiki i nā Microspheres ke ʻae i ka hoʻopili ʻana o 30%.
Hoʻolako ʻia nā Embolic Microspheres i sterile a hoʻopili ʻia i loko o nā ʻōmole aniani i hoʻopaʻa ʻia.
Ua manaʻo ʻia nā Embolic Microspheres e hoʻohana ʻia no ka embolization o nā arteriovenous malformations (AVMs) a me nā puʻupuʻu hypervascular, me nā fibroids uterine. Ma ka ālai ʻana i ke kahe koko i ka wahi i manaʻo ʻia, ua nele ka puʻupuʻu a i ʻole ka malformation i nā meaʻai a emi iho ka nui.
Hiki ke hāʻawi ʻia nā Embolic Microspheres ma o nā microcatheters maʻamau i ka pae 1.7-4 Fr. I ka manawa e hoʻohana ai, ua hui pū ʻia nā Embolic Microspheres me kahi mea hoʻohālikelike nonionic e hana i kahi hopena hoʻokuʻu. Ua manaʻo ʻia nā Embolic Microspheres no ka hoʻohana hoʻokahi a ua hāʻawi ʻia i sterile a non-pyrogenic. Ua wehewehe ʻia nā hoʻonohonoho ʻana o ka hāmeʻa o Embolic Microsphere ma ka Papa 1 a me ka Papa 2 ma lalo nei.
Ma waena o nā ʻano nui like ʻole o nā Embolic Microspheres, ʻo nā ʻano nui e hiki ke hoʻohana ʻia no ka uterine fibroid embolization he 500-700μm, 700-900μm a me 900-1200μm.
CE, ISO13485
ʻAmelika Hui Pū ʻIa FDA 510K
EN ISO 13485: 2016/AC:2016 ʻŌnaehana hoʻokele maikaʻi o nā lako lapaʻau no nā koi hoʻoponopono
EN ISO 14971: 2012 Nā mea lapaʻau - Hoʻopili ʻana i ka hoʻokele pilikia i nā mea lapaʻau
ISO 11135:2014 Mea lapaʻau Sterilization o ka ethylene oxide Hōʻoia a me ka kaohi laulā
ISO 6009:2016 Nā nila inikini sterile hoʻolei ʻia E ʻike i ke code kala
ISO 7864:2016 Nā nila inikini sterile hoʻolei ʻia
ISO 9626:2016 Nā paipu nila kila kila no ka hana ʻana i nā mea lapaʻau
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