ʻAʻole Degradable Elastic Design Polyvinyl Alcohol Embolic Microspheres
Hoʻohana ʻia nā Embolic Microspheres no ka embolization o arteriovenous malformations (AVMs) a me nā maʻi maʻi hypervascular, me nā fibroids uterine.
Ka inoa maʻamau a i ʻole: Polyvinyl Alcohol Embolic Microspheres
Inoa Hoʻohui: Vascular Embolization Device
Papahana: Papa II
Panel: Cardiovascular
ʻO Embolic Microspheres nā microspheres hydrogel compressible me ke ʻano maʻamau, ka ʻili maʻemaʻe, a me ka nui calibrated, i hoʻokumu ʻia ma muli o ka hoʻololi kemika i nā mea polyvinyl alcohol (PVA). ʻO Embolic Microspheres he macromer i loaʻa mai ka polyvinyl alcohol (PVA), a he hydrophilic, non-resorbable, a loaʻa i nā ʻano nui. ʻO ka hopena mālama he 0.9% ka hopena sodium chloride. ʻO ka ʻike wai o ka microsphere polymerized piha he 91% ~ 94%. Hiki i nā Microspheres ke ʻae i ka hoʻoemi ʻana o 30%.
Hāʻawi ʻia nā Embolic Microspheres sterile a hoʻopaʻa ʻia i loko o nā hue aniani i hoʻopaʻa ʻia.
Hoʻohana ʻia nā Embolic Microspheres no ka embolization o arteriovenous malformations (AVMs) a me nā maʻi maʻi hypervascular, me nā fibroids uterine. Ma ka pale ʻana i ka hāʻawi ʻana i ke koko i ka wahi i hoʻopaʻa ʻia, ua pōloli ka ʻōpū a i ʻole ka malformation i nā meaʻai a emi i ka nui.
Hiki ke hāʻawi ʻia nā Embolic Microspheres ma o nā microcatheters maʻamau i ka pae 1.7-4 Fr. I ka manawa o ka hoʻohana ʻana, ua hui pū ʻia nā Embolic Microspheres me kahi mea hoʻohālikelike nonionic e hana i kahi hopena hoʻomaha. Hoʻolālā ʻia nā Embolic Microspheres no ka hoʻohana hoʻokahi a hāʻawi ʻia i ka sterile a me ka non-pyrogenic. Hōʻike ʻia nā hoʻonohonoho hoʻonohonoho o ka Embolic Microsphere ma ka Papa 1 a me ka Papa 2 ma lalo nei.
Ma waena o nā ʻano nui like ʻole o Embolic Microspheres, ʻo nā pae nui e hiki ke hoʻohana ʻia no ka fibroid uterine embolization ʻo 500-700μm, 700-900μm a me 900-1200μm.
CE, ISO13485
USA FDA 510K
EN ISO 13485: 2016/AC: 2016 ʻōnaehana hoʻokele maikaʻi o ka lāʻau lapaʻau no nā koi hoʻoponopono.
EN ISO 14971: 2012 Nā mea lapaʻau - Ka hoʻohana ʻana i ka hoʻokele pilikia i nā mea lapaʻau
ISO 11135: 2014 Mea lapaʻau Sterilization o ka ethylene oxide Hōʻoia a me ka mana maʻamau
ISO 6009: 2016 Nā nila hoʻoheheʻe sterile hoʻokuʻu e ʻike i ke code kala
ISO 7864: 2016 ʻO nā nila hoʻoheheʻe sterile hoʻopau
ISO 9626: 2016 ʻO nā paipu nila kila kila no ka hana ʻana i nā mea lapaʻau
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