Elastic Design Polyvinyl Alcohol Embolic Microspheres anaghị emebi emebi
A na-ezubere iji microspheres embolic mee ihe maka mmechi nke akwara arteriovenous malformations (AVMs) na etuto hypervascular, gụnyere fibroids uterine.
Aha a na-ahụkarị ma ọ bụ aha mbụ: Polyvinyl Alcohol Embolic Microspheres
Aha nhazi ọkwa: Ngwaọrụ embolization vaskụla
Nhazi: Klas II
Ogwe: Cardiovascular
Embolic Microspheres bụ microspheres hydrogel compressible nwere udi oge niile, elu dị larịị, yana nha nha, nke emere n'ihi mgbanwe kemịkalụ na ihe polyvinyl mmanya (PVA). Embolic Microspheres nwere macromer nke sitere na mmanya polyvinyl (PVA), ma bụrụ hydrophilic, enweghị ike resorbable, ma dị n'ọtụtụ nha. Ihe ngwọta nchekwa bụ 0.9% sodium chloride ngwọta. Ọdịnaya mmiri nke microsphere polymerized zuru oke bụ 91% ~ 94%. Microspheres nwere ike ịnagide mkpakọ nke 30%.
A na-ebunye Microspheres Embolic ma tinye ya n'ime vial enyo mechiri emechi.
A na-ezubere iji microspheres embolic mee ihe maka mmechi nke akwara arteriovenous malformations (AVMs) na etuto hypervascular, gụnyere fibroids uterine. Site n'igbochi inye ọbara n'ebe a na-achọsi ike, akpụ ahụ ma ọ bụ ihe na-adịghị mma na-agụ agụụ nke nri ma na-ebelata nha.
Enwere ike ịnyefe Microspheres Embolic site na microcatheters a na-ahụkarị na nso 1.7-4 Fr. N'oge eji, Embolic Microspheres na-agwakọta ya na onye na-ahụ maka ọdịiche nke nonionic iji mepụta ngwọta nkwusioru. Embolic Microspheres bụ maka iji otu eme ihe, a na-ewetakwa ya adịghị ike na nke na-abụghị pyrogenic. A kọwara nhazi ngwaọrụ nke Embolic Microsphere na Tebụl 1 na Tebụl 2 n'okpuru.
N'etiti dị iche iche size ranges nke Embolic Microspheres, size ranges na ike ga-eji maka uterine fibroid emboliation bụ 500-700μm, 700-900μm na 900-1200μm.
CE, ISO13485
USA FDA 510K
TS EN ISO 13485: 2016 / AC: 2016 Sistemụ njikwa ogo akụrụngwa ọgwụ maka iwu chọrọ
TS EN ISO 14971 Ngwa ahụike - Ngwa njikwa ihe egwu na ngwaọrụ ahụike
TS EN ISO 11135: 2014 Ngwa ahụike ọgwụ mgbochi nke ethylene oxide nkwenye na njikwa izugbe
ISO 6009: 2016 agịga injection na-adịghị mma nke a na-atụfu ya Chọpụta koodu agba
TS EN ISO 7864: 2016 agịga injection na-enweghị atụ
TS EN ISO 9626: 2016 ọkpọkọ agịga igwe anaghị agba nchara maka imepụta ngwaọrụ ahụike
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