Subject has signed an informed consent form (ICF).;

Men = 45 years.;

Symptomatic BPH with the following (all must be met):;

IPSS = 13.;

Qmax = 12 mL/sec on a voided volume of = 125 mL.;

PVR < 250 mL.;

Prostate volume 30-80 cc measured by transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) within 6 months prior to randomization.;

Subjects willing to be off their BPH-related medications from time of enrollment and throughout study participation.;

Note: All subjects on BPH-related medications must start a washout period prior to qualifying questionnaires and uroflowmetry.

Subjects who meet ANY of the following exclusion criteria will not participate in the trial:

;Previous BPH procedure intended to disobstruct the bladder outlet (e.g., prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate).

;Obstructive protruding (mobile) middle (median) prostatic lobe as confirmed by cystoscopy.

;High bladder neck as determined by the Investigator.

;Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.

;Biopsy of the prostate within past 8 weeks.

;Baseline Prostate Specific Antigen (PSA) level \> 10 ng/mL or confirmed or suspected prostate cancer (subjects with a PSA level \> 2.5 ng/mL or whose PSA levels fall outside age-specific or local reference ranges, should have prostate cancer excluded to the Investigator's satisfaction in conjunction with shared decision making \[SDM\] with the study subjects).

;Confirmed or suspected bladder cancer.

;History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.

;History of neurogenic bladder.

;Previous episode of AUR, i.e., post hernia repair or other condition or disease that might cause urinary retention.

;Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).

;Serum creatinine \> 1.8 mg/dL or renal dysfunction attributed to bladder outlet obstruction (BOO).

;Concomitant UTI (subject can be enrolled following successful treatment of UTI and a negative UTI test), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months).

;Active infection including acute bacterial prostatitis.

;Previous pelvic irradiation or radical pelvic surgery.

;Known allergy to nickel.

;Subjects with life-threatening disease in which life expectancy is foreshortened are excluded.

;Desire to maintain fertility post-treatment.

;Anticipated need for additional major surgery or treatments for comorbidities during the study period (e.g., valve repair, organ transplant).

; Prostatic urethral length \< 25 mm or \> 60 mm, as measured from bladder neck to verumontanum, using cystoscopy just prior to randomization.

;Any concurrent medical condition or illness that might prevent study completion or that could impact the study results such as:

;severe cardiac arrhythmias uncontrolled by medications or pacemaker.

;congestive heart failure New York Heart Association (NYHA) III or IV.

;uncontrolled diabetes mellitus.

;significant respiratory disease in which hospitalization may be required.

;known immunosuppression (i.e., AIDS, post-transplant, undergoing chemotherapy).

;Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure.;

Note: Low dose aspirin therapy is acceptable.;

Unable or unwilling to complete all required questionnaires and follow-up assessments.

;Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

;Subject is in custody or institution, or, in the Investigator's opinion, has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).

• Gastroenterology

• Surgery (Colon and Rectal)

• Urology

• Prodeon Medical, Inc