General Information - VICTO EUA Instrucciones De Uso

GenerAl
inFOrMAtiOn
INDICATIONS FOR USE
victo is an adjustable artificial urinary
sphincter (aus) used to treat male stress
urinary incontinence caused by intrinsic
sphincter deficiency (isd) in cases such as
post-prostatectomy incontinence.
DEvICE CHARACTERISTICS
StArtEr Kit (Kit-AUS-37-WS; Kit-AUS-40-
WS; Kit-AUS-45-WS; Kit-AUS-50-WS)
the victo implant is a medical grade
silicone device which consists of a pressure
regulating balloon (prB), an urethral cuff, and
a control pump with a self-sealing port.
the necessary materials to set up the device
before to be implanted are included in the kit.
ACCESSORIES
CHARACTERISTICS
AccESSoriES Kit (Kit-Ac-01)
the accessories kit contains materials that
are necessary for the implantation procedure.
ADjUStmENt Kit (Kit-AD-06)
this kit contains the necessary materials to
adjust the system internal pressure by adding
or extracting sterile saline solution.
DEvICE FUNCTION
the victo implant has been developed to
simulate the normal function of the urethral
sphincter in order to maintain continence.
the device keeps the urethra closed by
means of an urethral cuff which prevents the
passage of urine. the pressure in the
cuff is regulated by a small silicone balloon
enGliSh
(pressure regulating balloon - prB). When
the patient wishes to void the cuff, it can be
deflated by manual operation of the control
pump which is placed in the scrotum. the fluid
in the cuff is transferred to the prB allowing
the urine to pass through the urethra.
the cuff automatically re-inflates through
a slow bleed valve in the control pump;
in addition, it can be manipulated for fast
re-inflation. the base of the control pump
contains a selfsealing port which enables the
device to be interrogated percutaneously in
order that extra fluid can be added to increase
the pressure.
Pump
A
· 3 ·
Figure 1
Pressure
regulating
balloon (PRB)
Cuff
Figure 2
Pressure-
regulating
b
balloon
Cuff
Pump unit with
self-sealing port