The Zenflow Spring System EU Safety and Performance Study

Inclusion Criteria:

1. Patient is able and willing to comply with all the assessments of the study
2. Patient or patient's legal representative has been informed of the nature of thestudy, agrees to participate and has signed the informed consent form
3. ≥ 45 years of age
4. Baseline IPSS score > 13, and a baseline Quality of Life (QoL) question score > 3
5. Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS) or abdominal ultrasound,measured within past 90 days and prostatic urethral length between 2.5- 4.5 cm
6. Failed, intolerant, or patient choice to not take a medication regimen for thetreatment of LUTS
7. Patient must meet ONE of the following criteria:
8. Baseline PSA <= 2.5ng/mL
9. Baseline PSA >2.5 ng/mL and <=10 ng/mL AND free PSA >=25% of total PSA (no biopsyrequired or negative biopsy)
10. Baseline PSA >10ng/mL AND negative prostate biopsy1 result within 12 months
11. Negative prostate biopsy1 within 12 months if abnormal digital rectal examination
12. 3 Tesla MRI of the prostate, with normal findings, within 12 months prior to thebaseline visit

Exclusion Criteria:

1. Obstructive intravesical median prostatic lobe which, in the opinion of theInvestigator, would not benefit from treatment
2. Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, orrecurrent requiring 2 or more dilations as reported in the patient's history
3. Requiring self-catheterization to void
4. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer
5. Any of the following, taken from a single uroflowmetry reading:
6. Peak urinary flow rate > 12 ml/second
7. Post-void residual (PVR) > 250 ml
8. Peak Urinary flow rate of > 15 ml/second
9. < 125ml urinary volume voided at baseline (pre-bladder urinary volume of ≥ 150 mlrequired)
10. Other condition or disease that might cause urinary retention
11. History of other diseases causing voiding dysfunction
12. Concomitant Urinary Tract Infection (UTI) (subject can be enrolled followingsuccessful treatment of UTI and a clean urine test), or a history of recurrent orchronic UTIs (defined as 2 or more UTIs in the past 12 months)
13. Concomitant bladder stones
14. Previous pelvic irradiation or radical pelvic surgery
15. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia oranother invasive treatment to the prostate
16. Chronic prostatitis, or recurring prostatitis within the past 12 months
17. Known allergy to nickel
18. Life expectancy less than 24 months
19. Use of concomitant medications (e.g., anticholinergics, antispasmodics orantidepressants) affecting bladder function
20. Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days priorto the procedure or coumadin for at least 5 days prior to the procedure (low doseaspirin therapy not prohibited)
21. Taking 5-alpha reductase inhibitors within 3 months of pre-treatment (baseline)evaluation unless evidence of same drug dose for at least 6 months with a stablevoiding pattern (the drug dose should not be altered or discontinued throughout thestudy)
22. Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation:
23. alpha-blockers,
24. androgens,
25. anticholinergics, or
26. cholinergic medication gonadotropin releasing hormonal analogs
27. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
28. phenylephrine, or
29. pseudoephedrine
30. Future fertility concerns
31. Any severe illness that might prevent study completion or would confound study results