I-Elastic Design Engaboli I-Polyvinyl Alcohol Embolic Microspheres
I-Embolic Microspheres ihloselwe ukusetshenziselwa ukuhlanganisa i-arteriovenous malformations (AVMs) kanye nezimila ze-hypervascular, kuhlanganise ne-uterine fibroids.
Igama Elivamile noma Elivamile: I-Polyvinyl Alcohol Embolic Microspheres
Igama Lokuhlukanisa: Idivayisi Yokuqinisa I-Vascular
Ukuhlukaniswa: Ikilasi II
Iphaneli: Inhliziyo
Ama-Embolic Microspheres ama-microsphere e-hydrogel acindezelayo anomumo ojwayelekile, indawo ebushelelezi, nosayizi olinganisiwe, akhiwa ngenxa yokuguqulwa kwamakhemikhali ezintweni ze-polyvinyl alcohol (PVA). I-Embolic Microspheres iqukethe i-macromer ethathwe ku-polyvinyl alcohol (PVA), futhi ayi-hydrophilic, ayi-resorbable, futhi atholakala ngebanga losayizi. Isixazululo sokulondoloza yisisombululo se-sodium chloride esingu-0.9%. Okuqukethwe kwamanzi e-microsphere eyenziwe nge-polymerized ngokugcwele kungama-91% ~ 94%. Ama-Microsphere angakwazi ukubekezelela ukucindezelwa okungama-30%.
I-Embolic Microspheres inikezwa inyumba futhi ifakwe ezitsheni zengilazi ezivaliwe.
I-Embolic Microspheres ihloselwe ukusetshenziselwa ukuhlanganisa i-arteriovenous malformations (AVMs) kanye nezimila ze-hypervascular, kuhlanganise ne-uterine fibroids. Ngokuvimbela ukunikezwa kwegazi endaweni okuhlosiwe, isimila noma ukukhubazeka kulambile ngenxa yezakhi zomzimba futhi ziyancipha ngosayizi.
I-Embolic Microspheres ingalethwa ngama-microcatheter ajwayelekile ebangeni elingu-1.7- 4 Fr. Ngesikhathi sokusetshenziswa, i-Embolic Microspheres ixubene ne-nonionic ejenti yokungafani ukuze yenze isisombululo sokumiswa. Ama-Embolic Microspheres ahloselwe ukusetshenziswa kanye futhi ahlinzekwa ayinyumba futhi angeyona i-pyrogenic. Ukulungiselelwa kwedivayisi ye-Embolic Microsphere kuchazwe kuThebula 1 nakuThebula 2 ngezansi.
Phakathi kobubanzi obuhlukahlukene bosayizi be-Embolic Microspheres, ububanzi besayizi obungasetshenziswa ekuhlanganisweni kwe-uterine fibroid yi-500-700μm, 700-900μm kanye no-900-1200μm.
CE, ISO13485
I-USA FDA 510K
I-TS EN ISO 13485: 2016/AC:2016 Uhlelo lokuphatha ikhwalithi yempahla yezokwelapha ngezidingo zokulawula
I-TS EN ISO 14971 Amadivayisi wezokwelapha ka-2012 - Ukusetshenziswa kokulawulwa kobungozi emishinini yezokwelapha
I-ISO 11135:2014 Idivaysi yezokwelapha Ukuvalwa inzalo kwe-ethylene oxide Ukuqinisekisa nokulawula okujwayelekile
I-ISO 6009:2016 Izinaliti zomjovo oyinyumba ezilahlwayo Thola ikhodi yombala
I-ISO 7864: 2016 Izinaliti zomjovo oyinyumba ezilahlwayo
I-ISO 9626:2016 Amashubhu enaliti ensimbi engagqwali okwakhiwa kwemishini yezokwelapha
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