Имплантаты жидкие неадгезивные для эндоваскулярной эмболизации: системы эмболизирующие жидкие Menox™: система эмболизирующая жидкая Menox™34 в составе:

Χώρα: Λευκορωσία

Γλώσσα: Ρωσικά

Πηγή: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Διαθέσιμο από:

Meril Life Sciences Pvt. Ltd., ИНДИЯ

Kατηγορία:

изделия медицинского назначения

Κατασκευάζεται από:

Meril Life Sciences Pvt. Ltd.

Ημερομηνία της άδειας:

2023-04-03

Αρχείο Π.Χ.Π.

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.