General Information - Promedon VICTO+ Instructions D'utilisation

GENERAL
INFORMATION
INDICATIONS FOR USE
VICTO+ is an adjustable artificial urinary
sphincter (AUS) used to treat male stress
urinary incontinence
sphincter deficiency (ISD) in cases such as
post-prostatectomy incontinence.
PATIENT SELECTION CRITERIA
Prior to implanting VICTO+, the patient has to
be selected after undergoing preoperative tests
and subsequently evaluated by the surgeon.
VICTO+ is designed to treat patients who
suffer from stress
following prostate
evidence demonstrates that the artificial urinary
sphincters are sometimes implanted after
another surgery has failed (e.g. slings) and this
does not increase complications or compromise
success after a subsequent artificial urinary
sphincter.
This product should not be implanted in female
patients or children.
DEVICE CHARACTERISTICS
STARTER KIT (KIT-VICTO+-37;
KIT-VICTO+-40; KIT-VICTO+-45;
KIT-VICTO+-50; KIT-VICTO+-55)
This starter kit contains the VICTO+ implant
and the device identification card to be filled out
by the healthcare institution.
VICTO+ is a medical grade silicone device that
consists of a pressure regulating balloon (PRB),
a stress relief balloon (SRB) (which only works
in cases of high intra-abdominal pressure), a
urethral cuff, and a control pump with a self-
sealing port.
caused by intrinsic
urinary incontinence
surgery. The clinical
ACCESSORIES
CHARACTERISTICS
ACCESSORIES KIT (KIT-AC-02)
The Accessories Kit contains materials that are
necessary for the implantation procedure.
DEVICE FUNCTION
VICTO+ 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 a urethral cuff, which prevents the passage
of urine. The pressure in the cuff is regulated
by a small silicone balloon (pressure regulating
balloon, PRB). An additional balloon is placed
in series with the cuff; the purpose of this
balloon (stress relief balloon, SRB) is to transfer
additional fluid to the cuff only during periods
of high intra-abdominal pressure such as
coughing and sneezing. This feature is called
"conditional occlusion." 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 self-sealing
port that enables the device to be adjusted
percutaneously, injecting extra fluid to increase
the pressure of the system.
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