Country: Hvíta-Rússland
Tungumál: rússneska
Heimild: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Meril Life Sciences Pvt. Ltd., ИНДИЯ
изделия медицинского назначения
Meril Life Sciences Pvt. Ltd.
2023-04-03
1. DEVICE NAME: The device brand name is Menox . The generic name is Liquid Embolic TM System. 2. DEVICE DESCRIPTION: M TM enox Liquid Embolic System (LES) is available in three (03) model variants: TM 1) Menox Liquid Embolic System (18 cSt viscosity) (5% EVOH) TM 2) Menox Liquid Embolic System (20 cSt viscosity) (6% EVOH) TM 3) Menox Liquid Embolic System (34 cSt viscosity) (7% EVOH) TM The Menox Liquid Embolic System consists of following components: - Menox 18/Menox 20/Menox 34 Liquid Embolic Material (LEM)(1.5 ml vial ) - Dimethyl sulfoxide (DMSO) (1.5 ml vial) - 1 ml DMSO compatible syringe (3 nos.) TM Menox Liquid Embolic System is intended for Presurgical Embolization of brain Arteriovenous Malformation (bAVMs). TM TM 1) Menox LES (18 cSt ) and Menox LES (20 cSt) - Recommended when feeding pedicle injections will be conducted close to nidus of brain Arteriovenous Malformations (bAVM) TM 2) Menox LES (34 cSt) - Recommended for embolizing higher flow and larger fistulous components. Menox Liquid Embolic Material is non-adhesive liquid embolic agent comprised of EVOH (ethylene vinyl alcohol) copolymer dissolved in DMSO (dimethyl sulfoxide), and suspended micronized tantalum powder to provide contrast for visualization under fluoroscopy (radiopacity). Dimethyl sulfoxide (DMSO) act as a flushing agent. DMSO is injected to fill the dead space of micro catheter prior to injection of Menox. Injection of DMSO prevents the unintentional precipitation of Menox, which immediately begins when there is contact to water, saline solution or blood. A total of 03 DMSO compatible 1 ml syringes are provided to deliver Menox and DMSO. Two white colored piston syringes are used to deliver Menox and one blue colored piston syringe is used to deliver DMSO. Menox LEM is delivered by slow controlled injection through a micro catheter into the brain arteriovenous malformation under fluoroscopic control. DMSO compatible delivery micro catheter that is indicated for use in the neuro vasculature is used to access the embolization site. Lestu allt skjalið