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12 months ago

Politano-Sayet-Sutherland Flow Control Device (PSS-FCD)

The PSS-FCD is designed to treat severe Urinary Incontinence (UI). It is expected to arrest the uncontrollable flow of urine, better than any product or medical procedure currently available. It is made up of two component parts, the cable/valve assembly and the control box unit.

The cable/valve assembly has two separate pieces, including the full cable/valve assembly itself and a backside piece that is coupled with the cable/valve assembly for placement around the urethra. The cable/assembly consists of the actual valve (plunger) piece, which is connected to the cable that acts as the conduit to the control box unit. This operates to pull or push the valve either against, or away from, the urethra controlling the flow of urine through the urethra. The cable assembly was also designed with a backside piece that forms a complete shell around the urethra, when snapped into place with the main piece of the cable/valve assembly, during placement of the device in the patient.

The control box unit contains the other operational components of the product, including the motor assembly, the power supply and the PC-board. The combination of the control box unit and the cable/valve assembly, enable the device to open and close on the patient’s urethra allowing control of the flow of urine through the urethra.

Procedure Features

  • Designed to work equally well in both men and women.
  • Designed to be implanted in a relatively easy 15-20 minute procedure.
  • Tension-free around urethra.
  • Multiple closure pressure settings for optimal fit, adjustable by the physician, personalized to the patient’s specific needs.
  • Patient or caretaker controls the opening and closing of the valve with the push of a button.
  • Fail safe, backup systems in the event the unit loses power, patient loses hand-held control mechanism or a valve obstruction forms.
  • Easy to upgrade and replace power-supply and control box via a 15-minute, outpatient office procedure, which is expected be done every 4-5 years.