Safety and Effectiveness Study of the Zenflow Spring System

The Zenflow Spring Implant is an electropolished and passivated nickel titanium alloy (nitinol) implant. The implant is constructed from a single wire strand formed into ring elements connected by spine sections. There are four sizes of implants ranging from 16 mm to 24 mm in length and 14 mm to 16 mm in diameter to implant in the subject's prostatic urethra. The implant is placed in the urethra using a custom delivery catheter and cystoscope (Spring Scope). The implant is intended to be permanent but can be removed if necessary.

A18 Fr Foley Catheter is placed into the patient's bladder. To mimic the Treatment Arm procedure, the Foley Catheter balloon will be inflated in the bladder. Once inflated, slight tension will be applied against the subject's bladder neck. While tension is being applied the site staff will follow a script to simulate the Zenflow procedural steps. Additionally, devices will be used to produce mock deployment sounds of the Zenflow procedure. Once complete, the balloon will be deflated and the catheter will be removed, completing the procedure.