Izinkomba Zokusebenzisa (Chaza)
Ama-Microsphere e-Emboliczenzelwe ukusetshenziselwa ukuvimbela ukukhubazeka kwemithambo yegazi (ama-AVM) kanye nezimila zemithambo yegazi, okuhlanganisa ne-uterine fibroids.
Igama Elivamile noma Elijwayelekile: Ukuhlukaniswa Kwe-Polyvinyl Alcohol Embolic Microspheres
Igama: Idivayisi Yokumbolisa Imithambo Yemithambo
Ukuhlukaniswa: Isigaba II
Iphaneli: Inhliziyo Nemithambo Yegazi
Incazelo Yedivayisi
Ama-Embolic Microspheres angama-microspheres e-hydrogel acindezelwayo anesimo esijwayelekile, ubuso obubushelelezi, kanye nosayizi olinganisiwe, akhiwa ngenxa yokuguqulwa kwamakhemikhali ezintweni ze-polyvinyl alcohol (PVA). Ama-Embolic Microspheres aqukethe i-macromer etholakala ku-polyvinyl alcohol (PVA), futhi ayathandeka emanzini, awakwazi ukusongelwa, futhi atholakala ngobukhulu obuhlukahlukene. Isixazululo sokugcina siyisisombululo se-sodium chloride esingu-0.9%. Okuqukethwe kwamanzi kwe-microsphere egcwele i-polymer kungu-91% ~ 94%. Ama-Microspheres angabekezelela ukucindezelwa okungu-30%.
Ama-Embolic Microspheres anikezwa ahlanzekile futhi apakishwe emabhodleleni engilazi avaliwe.
Ama-Embolic Microspheres ahloselwe ukusetshenziselwa ukuvimbela ukukhubazeka kwemithambo yegazi (ama-AVM) kanye nezimila ezithwala igazi eliningi, okuhlanganisa ne-uterine fibroids. Ngokuvimba ukuphakelwa kwegazi endaweni okuqondiwe kuyo, isimila noma ukukhubazeka kuyaphela izakhamzimba futhi kunciphe ngobukhulu.
Ama-Embolic Microspheres angalethwa ngama-microcatheters ajwayelekile kububanzi be-1.7-4 Fr. Ngesikhathi sokusetshenziswa, ama-Embolic Microspheres axutshwa ne-ejenti yokungafani engeyona i-ionic ukuze kwakheke isixazululo sokumiswa. Ama-Embolic Microspheres enzelwe ukusetshenziswa kanye futhi anikezwa ahlanzekile futhi angenawo ama-pyrogenic. Ukucushwa kwedivayisi ye-Embolic Microsphere kuchazwe kuThebula 1 kanye neThebula 2 ngezansi.
Phakathi kwezinhlobo ezahlukene zobukhulu be-Embolic Microspheres, izinhlobo zobukhulu ezingasetshenziswa ekufakweni kwe-uterine fibroid yi-500-700μm, 700-900μm kanye ne-900-1200μm.
| Ithebula: Ukucushwa kwedivayisi ye-Embolic Microspheres | ||||
| Umkhiqizo Ikhodi | Kulinganisiwe Usayizi (µm) | Ubuningi | Isibonakaliso | |
| Izimila Ezine-Hypervascular/ I-Arteriovenous Ukukhubazeka | I-Fibroid Yesibeletho | |||
| B107S103 | 100-300 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | No |
| B107S305 | 300-500 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | No |
| B107S507 | 500-700 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| B107S709 | 700-900 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| B107S912 | 900-1200 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| B207S103 | 100-300 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | No |
| B207S305 | 300-500 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | No |
| B207S507 | 500-700 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| B207S709 | 700-900 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| B207S912 | 900-1200 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| Umkhiqizo Ikhodi | Kulinganisiwe Usayizi (µm) | Ubuningi | Isibonakaliso | |
| Izimila Ezine-Hypervascular/ I-Arteriovenous Ukukhubazeka | I-Fibroid Yesibeletho | |||
| U107S103 | 100-300 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | No |
| U107S305 | 300-500 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | No |
| U107S507 | 500-700 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| U107S709 | 700-900 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| U107S912 | 900-1200 | Ama-microspheres angu-1ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| U207S103 | 100-300 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | No |
| U207S305 | 300-500 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | No |
| U207S507 | 500-700 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| U207S709 | 700-900 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
| U207S912 | 900-1200 | Ama-microspheres angu-2ml: 7ml 0.9% i-sodium chloride | Yebo | Yebo |
Isikhathi sokuthunyelwe: Feb-27-2024








