The inflow Active Data Collection The inflow Patient Support System (PSS)
Female Indication Urinary for Prosthesis Use inflow device Internal valve-pump Activator remote control
How Indication the inflow for Works Use inflow device is inserted into urethra and remains in place for 29 days Pressing Activator button engages internal pump Pumps urine out of bladder at a normal flow rate Allows dignified urination on demand
Good Bladder Health with the inflow Good bladder health requires Periodic Forceful and Complete evacuation of urine The InFlow mimics normal urination and unlike urinary catheters, maintains all of these key functions As a result, inflow users can experience significant benefits Decreased UTI rate Increased convenience (voiding takes a normal amount of time) Improved personal dignity
Supporting Patients in Effective Device Use Transitioning patients from catheters to effective use of the inflow may require certain behavioral changes Indwelling catheter users are not accustomed to timed voiding Intermittent catheter users often restrict hydration to limit catheterizations The inflow Patient Support System (PSS) is intended to: Support patients in making beneficial behavioral changes Provide ongoing monitoring of their bladder function
Active Data Collection PSS integrates 3 functions to make up a Comprehensive Voiding Profile 1. Remote Patient Monitoring 2. Support for Healthy Behaviors 3. Voiding Diary Three Components Smart Activator Base Station Take Control ios app
Level 1: Remote Patient Monitoring The inflow PSS collects key clinical data automatically No patient initiative required for monitoring voiding frequency or volume Additional levels of patient support and data collection dependent on users Each time the Activator button is used It calculates the amount of urine pumped out of the bladder
Collecting Key Clinical Data When not in use, Activator is placed in Base Station Base Unit recharges Activator and downloads voiding data Data are uploaded to Cloud daily
2. Patient Using Key Monitoring Clinical Data (Background to Trigger AlertsDAC)
Level 2: Support for Healthy Behaviors Proper hydration and routine voiding are critical for bladder health The Take Control app for ios devices prompts patients to void per schedule and meet hydration goals Default settings can be adjusted by clinician Optional tracking of compliance to prompts
Level 3: Voiding Diary The Take Control app also collects voiding diary (event) data Number and severity of leaks Number and severity of urge episode Fluid intake Clinical value of voiding diary data is potentiated by automatic collection of accurate voiding output measurements Voiding diary data do require routine interaction by patient Unlikely to be maintained, so recommended for limited use Initial device use to provide baseline and periodically thereafter
The PSS Comprehensive Voiding Profile Integration of all data comprises a comprehensive profile of voiding function that can be used to monitor and support the health of patients
Powerful, Meaningful Insight into Voiding Function Ongoing monitoring of key metrics concerning patient health Management tool for both clinicians and payers to judge patient-specific effectiveness of therapies, including the effects of medications
Summary of PSS Functionality Automatically collects and transmits clinically key data, such as voiding frequency and volume, without requiring any initiative by patient Can alert designated clinician if clinically key data indicates a health risk Prompts patient concerning healthy behaviors Tracks compliance with prompts Requires as little effort by the patient as possible to collect other data Works long-term with little or no need for maintenance
And the inflow PSS does all this while providing unprecedented bladder control and dignity for patients