The purpose of this registry is to collect information on how the Zenflow Spring System works in everyday medical practice. The registry will track how the Spring System performs during the implant procedure, and at follow-up visits at 1, 3, 6, and 12 months. We will look at how symptoms improve, how quickly patients return to normal activities, how satisfied they are with treatment, and whether there are any problems or side effects related to the device.
Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.
Case-only
Prospective
Zenflow Spring System
DeviceMinimally Invasive Treatment for LUTS associated with BPH
Effectiveness - IPSS
The primary effectiveness endpoint is the change in IPSS from baseline over time
Safety - adverse events
The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs)
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