Magadzirirwo Epurasitiki Asingaparare Anogona Kuora ePolyvinyl Alcohol Embolic Microspheres
Embolic Microspheres yakagadzirirwa kushandiswa pakudzivirira kukuvara kwe arteriovenous malformations (AVMs) uye bundu re hypervascular, kusanganisira uterine fibroids.
Zita Rinowanzozivikanwa kana Rinowanzozivikanwa: Polyvinyl Alcohol Embolic Microspheres
Zita reKupatsanura: Chishandiso cheKubvisa Mitsipa yeropa
Kupatsanura: Kirasi II
Panel: Mwoyo neMwoyo
Embolic Microspheres imhando yehydrogel microspheres inodzvanywa ine chimiro chakajairwa, pamusoro payo pakatsetseka, uye saizi yakaganhurirwa, iyo inoumbwa nekuda kwekuchinja kwemakemikari pazvinhu zvepolyvinyl alcohol (PVA). Embolic Microspheres ine macromer inobva kupolyvinyl alcohol (PVA), uye inopfava, haibvisike, uye inowanikwa muhukuru hwakasiyana. Mhinduro yekuchengetedza i0.9% sodium chloride solution. Mvura iri mu microsphere yakazara polymerized i91% ~ 94%. Microspheres inogona kutsungirira kudzvanywa kwe30%.
Embolic Microspheres inowanikwa isina utachiona uye inoiswa mumabhodhoro egirazi akavharwa.
MaEmbolic Microspheres akagadzirirwa kushandiswa pakudzivirira kukuvara kwetsinga dzeropa (AVMs) uye bundu reropa, kusanganisira uterine fibroids. Nekuvharira ropa kusvika panzvimbo yaunoda, bundu kana kukuvara kwetsinga kunoshaya zvinovaka muviri uye kunoderedza saizi.
Embolic Microspheres inogona kuendeswa kuburikidza nema microcatheters akajairika ari muhuwandu hwe1.7-4 Fr. Panguva yekushandiswa, Embolic Microspheres inosanganiswa ne nonionic contrast agent kuti igadzire suspension solution. Embolic Microspheres yakagadzirirwa kushandiswa kamwe chete uye inowanikwa isina utachiona uye isingakuvadzi pyrogenic. Magadzirirwo emidziyo yeEmbolic Microsphere anotsanangurwa muTafura 1 neTafura 2 pazasi.
Pakati pemhando dzakasiyana dzeEmbolic Microspheres, mhando dzehukuru dzinogona kushandiswa pakubvisa uterine fibroid ndedze 500-700μm, 700-900μm uye 900-1200μm.
CE, ISO13485
USA FDA 510K
EN ISO 13485: 2016/AC: 2016 Sisitimu yekutarisira mhando yemidziyo yekurapa maererano nezvinodiwa nemutemo
EN ISO 14971: 2012 Zvishandiso zvekurapa - Kushandiswa kwekutarisira njodzi kumidziyo yekurapa
ISO 11135:2014 Chishandiso chekurapa Kuchenesa ethylene oxide Kusimbiswa uye kudzorwa kwakajairika
ISO 6009:2016 Tsinga dzejekiseni dzisina utachiona dzinoraswa. Ratidza kodhi yeruvara
ISO 7864:2016 Tsinga dzejekiseni dzisina utachiona dzinoraswa
ISO 9626:2016 Machubhu esimbi isina ngura ekugadzira michina yekurapa
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