Isingaparare Elastic Dhizaini Polyvinyl Doro Embolic Microspheres
Embolic Microspheres inotarisirwa kushandiswa kumisa arteriovenous malformations (AVMs) uye hypervascular tumors, kusanganisira uterine fibroids.
Yakajairika kana Yakajairika Zita: Polyvinyl Doro Embolic Microspheres
Zita Rokuronga: Vascular Embolization Device
Classification: Kirasi II
Panel: Cardiovascular
Embolic Microspheres ndeye compressible hydrogel microspheres ine chimiro chenguva dzose, yakatsetseka pamusoro, uye saizi yakarongedzerwa, iyo inoumbwa semhedzisiro yekugadziriswa kwemakemikari pane polyvinyl doro (PVA) zvinhu. Embolic Microspheres ine macromer inotorwa kubva ku polyvinyl doro (PVA), uye ndeye hydrophilic, isingadzokeke, uye inowanikwa muhukuru hwakasiyana. Mushonga wekuchengetedza ndeye 0.9% sodium chloride solution. Iyo yemvura yemukati yakazara polymerized microsphere ndeye 91% ~ 94%. Microspheres inogona kushivirira compression ye30%.
Embolic Microspheres inopihwa isina hutachiona uye yakaputirwa mumabhodhoro egirazi akavharwa.
Embolic Microspheres inotarisirwa kushandiswa kumisa arteriovenous malformations (AVMs) uye hypervascular tumors, kusanganisira uterine fibroids. Nekuvharira kupihwa kweropa kunzvimbo yakatariswa, bundu kana malformation inoziya nenzara uye inoderera muhukuru.
Embolic Microspheres inogona kuendeswa kuburikidza neyakajairwa microcatheters mu 1.7- 4 Fr renji. Panguva yekushandiswa, Embolic Microspheres inosanganiswa neinoonic inosiyanisa mumiriri kuti igadzire mhinduro yekumisa. Embolic Microspheres inoitirwa kushandiswa kamwe chete uye inopihwa isina hutachiona uye isiri-pyrogenic. Magadzirirwo emidziyo yeEmbolic Microsphere anotsanangurwa muTable 1 uye Tafura 2 pazasi.
Pakati pehukuru hwakasiyana-siyana hweEmbolic Microspheres, hukuru hukuru hunogona kushandiswa kuitisa uterine fibroid embolization ndeye 500-700μm, 700-900μm uye 900-1200μm.
CE, ISO13485
USA FDA 510K
TS EN ISO 13485: 2016 / AC: 2016 Zvigadzirwa zvekurapa zvemhando yepamusoro system yezvinodiwa zvekutonga
TS EN ISO 14971 Zvishandiso zvekurapa 2012 - Kushandiswa kwekutonga kwenjodzi kumidziyo yekurapa
TS EN ISO 11135: 2014 Chishandiso chekurapa Kugadziriswa kwe ethylene oxide Kusimbisa uye kutonga kwakawanda
ISO 6009:2016 Tsono dzejekiseni dzinoraswa Ziva kodhi yeruvara
ISO 7864:2016 Tsono dzejekiseni dzinoraswa
ISO 9626: 2016 Simbi isina tsvina machubhu ekugadzira michina yekurapa
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Neanopfuura makore gumi ehutano hwekugovera ruzivo, isu tinopa yakafara chigadzirwa kusarudzwa, yemakwikwi mitengo, akasarudzika masevhisi eOEM, uye akavimbika pa-nguva kuendesa. Isu tanga tiri mutengesi weHurumende yeAustralia Dhipatimendi rehutano (AGDH) uye California Dhipatimendi rePublic Health (CDPH). MuChina, isu tinomira pakati pevanopa vepamusoro veInfusion, Jekiseni, Vascular Access, Rehabilitation Equipment, Hemodialysis, Biopsy Needle uye Paracentesis zvigadzirwa.
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Takawana mukurumbira wakanaka pakati pevatengi ava vese vebasa rakanaka uye mutengo wemakwikwi.
A1: Tine makore gumi ruzivo mundima iyi, Kambani yedu ine timu yehunyanzvi uye mutsara wekugadzira wehunyanzvi.
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