Igishushanyo mbonera cya Elastike kitagabanuka Polyvinyl Inzoga Embolic Microspheres

ibicuruzwa

Igishushanyo mbonera cya Elastike kitagabanuka Polyvinyl Inzoga Embolic Microspheres

Ibisobanuro bigufi:

Embolic Microspheres igenewe gukoreshwa mu kurandura indwara ya arteriovenous malformations (AVMs) hamwe n'ibibyimba bya hypervasculaire, harimo na fibroide nyababyeyi.


Ibicuruzwa birambuye

Ibicuruzwa

microsperes ya embolic (14)
microsperes ya embolic (12)
microsperes ya embolic (13)

Gushyira mu bikorwa Microsperes

Embolic Microspheres igenewe gukoreshwa mu kurandura indwara ya arteriovenous malformations (AVMs) hamwe n'ibibyimba bya hypervasculaire, harimo na fibroide nyababyeyi.

Izina risanzwe cyangwa risanzwe: Polyvinyl Alcool Embolic Microspheres

Izina Ryiciro: Igikoresho cya Embolisation

Ibyiciro: Icyiciro cya II

Ikibaho: Imitsi

Microspheres ya Embolic (6)

Ibisobanuro ku bicuruzwa byaEmbolic Microspheres

Embolic Microspheres ni microsperes ya hydrogel ishobora guhindagurika ifite imiterere isanzwe, hejuru yubuso, hamwe nubunini bwa Calibrated, ibyo bikaba biterwa no guhindura imiti kubikoresho bya alcool ya polyvinyl (PVA). Microspheres ya Embolic igizwe na macromer ikomoka kuri alcool ya polyvinyl (PVA), kandi ni hydrophilique, idasubirwaho, kandi iraboneka mubunini. Igisubizo cyo kubungabunga ni 0,9% sodium chloride yumuti. Amazi ya microse yuzuye yuzuye ni 91% ~ 94%. Microsperes irashobora kwihanganira kwikuramo 30%.
Microspheres ya Embolic itangwa sterile kandi igapakirwa mubirahuri bifunze.
Embolic Microspheres igenewe gukoreshwa mu kurandura indwara ya arteriovenous malformations (AVMs) hamwe n'ibibyimba bya hypervasculaire, harimo na fibroide nyababyeyi. Muguhagarika gutanga amaraso ahantu hagenewe, ikibyimba cyangwa malformation yicishijwe inzara nintungamubiri kandi igabanuka mubunini.
Embolic Microspheres irashobora gutangwa binyuze muri microcatheters isanzwe ya 1.7- 4 Fr. Mugihe cyo gukoresha, Microspheres ya Embolic ivangwa numuntu utandukanya ibintu kugirango bibe igisubizo gihagarikwa. Embolic Microspheres igenewe gukoreshwa rimwe kandi itangwa sterile kandi itari pyrogene. Ibikoresho bya Microse ya Embolic byasobanuwe mu mbonerahamwe ya 1 na Imbonerahamwe 2 hepfo.
Mubunini butandukanye bwa Microspheres ya Embolic, ingano yubunini bushobora gukoreshwa muri embolisation ya nyababyeyi ni 500-700 mm, 700-900μm na 900-1200μm.

Amabwiriza:

CE, ISO13485
Amerika FDA 510K

Igipimo:

EN ISO 13485: 2016 / AC: 2016 Sisitemu yubuvuzi bwiza bwibikoresho byubuvuzi kubisabwa n'amategeko
EN ISO 14971: 2012 Ibikoresho byubuvuzi - Gukoresha uburyo bwo gucunga ibyago kubikoresho byubuvuzi
ISO 11135: 2014 Igikoresho cyubuvuzi Kurandura okiside ya Ethylene Kwemeza no kugenzura rusange
ISO 6009: 2016 Urushinge rushobora guterwa inshinge Menya kode yamabara
ISO 7864: 2016 Urushinge rwo gutera inshinge
ISO 9626: 2016 Imiyoboro y'urushinge idafite ibyuma kugirango ikore ibikoresho byubuvuzi

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