The implant procedure to place the valve of the PSS-FCD around the urethra, and the control box unit subcutaneously in the abdominal area, should take under 20 minutes. No special measurements or placement settings will be required during surgery. The urethral valve will be placed in the full open position, as the actual constriction adjustments are done after the implant is completed, via the on-board remote telemetry adjustment system, during follow-up visits to the physician’s office. There will be no limitations on the number of times a physician will be able to “fine tune” adjust the valve for the patient, virtually eliminating the guesswork on how tightly or loosely to set the valve during implant, in order to obtain the optimal treatment setting for each and every patient.
The PSS-FCD will simply constrict the flow of urine through the urethra until the patient clicks the small, hand-held triggering mechanism (much like a car-key entry system) near the control unit implanted under the patient’s skin in the abdominal area, opening the internal valve. Another click; and the internal valve will close again.