How Is the inFlow Used

Female Voiding Prosthesis

FDA Indications for Use

The inFlow Intraurethral Valve-Pump and Activator is a replaceable urinary prosthesis that is intended for use in female patients 18 years of age or older who have incomplete bladder emptying due to impaired detrusor contractility of neurologic origin, and who are capable of operating it in accordance with instructions or who have trained caregivers. The device must be replaced every 29 days (or less).

Instructions

Physician IFU for the inFlow Device and Activator (PDF)
Physician IFU for the inFlow Measuring Device (PDF)
Patient Instructions for the inFlow Device and Activator (PDF)
Patient Supplemental Instructions for Activator (PDF)

 



Device Use

 

Device Insertion and Removal

The inFlow device is available in 9 sizes in order to accommodate individual patient anatomy. Prior to initial device insertion, the inFlow Sizing device is used to measure urethral length in order to determine the appropriate inFlow device size. Urethral length measurement and initial inFlow device insertion are performed by a clinician, usually a urologist. Preparation for insertion is similar to that for a urinary catheter.

Following insertion (1), the device is deployed by pushing the plunger on its disposable introducer (2). The deployed device resides almost entirely in the urethra (3). As with an indwelling (Foley) catheter, the inFlow device should be removed and replaced every 29 days. The device can be easily and safely removed at any time, even by patients, by simply grasping its tab and pulling straight out (4).