Uyilo lwe-Elastic olungaguqukiyo lwe-Polyvinyl Alcohol Embolic Microspheres
Ii-Microspheres ze-Embolic zenzelwe ukusetyenziselwa ukunyanzeliswa kwe-arteriovenous malformations (AVMs) kunye ne-hypervascular tumors, kuquka i-uterine fibroids.
Igama eliqhelekileyo okanye eliQhelekileyo: iPolyvinyl Alcohol Embolic Microspheres
Igama loHlelo: Isixhobo seVascular Embolization
Ukuhlelwa: Udidi II
Iphaneli: Intliziyo
I-Embolic Microspheres i-compressible hydrogel microspheres enemilo eqhelekileyo, indawo egudileyo, kunye nobukhulu obulinganisiweyo, obunjwe ngenxa yokuguqulwa kweekhemikhali kwizinto ze-polyvinyl alcohol (PVA). I-Embolic Microspheres iqulethe i-macromer evela kwi-polyvinyl alcohol (PVA), kwaye i-hydrophilic, i-non-resorbable, kwaye ifumaneka kuluhlu lweesayizi. Isisombululo sokugcina yi-0.9% yesisombululo se-sodium chloride. Isiqulatho samanzi se-polymerized microsphere ngokupheleleyo yi-91% ~ 94%. I-Microspheres inokunyamezela ukunyanzeliswa kwe-30%.
I-Embolic Microspheres zibonelelwa zinyumba kwaye zipakishwe kwiibhotile zeglasi ezitywiniweyo.
Ii-Microspheres ze-Embolic zenzelwe ukusetyenziselwa ukunyanzeliswa kwe-arteriovenous malformations (AVMs) kunye ne-hypervascular tumors, kuquka i-uterine fibroids. Ngokuthintela ukunikezelwa kwegazi kwindawo ekujoliswe kuyo, i-tumor okanye i-malformation ilambile izondlo kwaye iyancipha ngobukhulu.
I-Embolic Microspheres inokuhanjiswa ngee-microcatheters eziqhelekileyo kuluhlu lwe-1.7-4 Fr. Ngexesha lokusetyenziswa, i-Embolic Microspheres ixutywe kunye ne-agent engafaniyo ye-nonionic ukwenza isisombululo sokumiswa. Ii-Microspheres ze-Embolic zenzelwe ukusetyenziswa okukodwa kwaye zibonelelwa ngeenyumba kunye ne-non-pyrogenic. Ukucwangciswa kwesixhobo se-Embolic Microsphere kuchazwe kwiThebhile 1 kunye neThebhile 2 ngezantsi.
Phakathi kweentlobo ezahlukeneyo zobukhulu be-Embolic Microspheres, ububanzi besayizi obunokusetyenziswa kwi-uterine fibroid embolization yi-500-700μm, 700-900μm kunye ne-900-1200μm.
CE, ISO13485
I-USA FDA 510K
I-EN ISO 13485: 2016/AC:2016 Inkqubo yolawulo lwezixhobo zonyango kwiimfuno zolawulo
I-EN ISO 14971 : Izixhobo zonyango ze-2012-Ukusetyenziswa kolawulo lomngcipheko kwizixhobo zonyango
I-ISO 11135: 2014 Isixhobo soNyango Ukwenziwa inzala kwe-ethylene oxide Ukuqinisekiswa kunye nolawulo jikelele
I-ISO 6009: 2016 Iinaliti ezilahlwayo zenaliti engasebenziyo Chonga ikhowudi yombala
I-ISO 7864: 2016 Iinaliti ezilahliweyo zenaliti
I-ISO 9626: I-2016 Iityhubhu zeenaliti zensimbi ezingenasici zokwenza izixhobo zonyango
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