A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms

Inclusion Criteria:

• Male subjects > 45 years of age who have symptomatic BPH

• International Prostate Symptom Score (IPSS) score >13

• Peak urinary flow rate (Qmax): >5 mL/sec and <13 mL/sec with minimum voided volumeof >125 mL

• Post-void residual (PVR) <250 mL

• Prostate volume 25 to 80 mL

• Prostatic urethral length 20-50 mm

• Able to complete the study protocol and visits

Exclusion Criteria:

• Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate

• Prior minimally invasive intervention or surgical intervention of the prostate orurethra

• PSA >10 ng/mL

• Bladder cancer or bladder stones

• Active urinary tract infection (UTI)

• Uncontrolled diabetes

• Part of a vulnerable population (cognitively challenged or are incarcerated)