Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia

The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).

Inclusion Criteria: 1. Male 45-80 years of age 2. Diagnosed with Benign prostatic hyperplasia (BPH) 3. Prostate volume: ≥ 40 ≤ 100 cc measured by MRI 4. Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL) 5. Assessment of future paternity plans 6. Signed the study informed consent 7. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12 Exclusion Criteria: 1. Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy. 2. Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable 3. Intravesical prostatic protrusion (IPP) \> 10 mm 4. Post-void residual volume (PVR) \> 200ml 5. IPSS QoL score ≤ 3 6. Prostate cancer diagnosis, suspicious DRE, or PSA \> 10ng/mL 7. Patients with clinical history of chronic prostatitis. 8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days), or urethral strictures. 9. Major neurological conditions such as Alzheimer's, Parkinsons, Multiple sclerosis, ALS, spinal cord injury 10. Patients who are unable to undergo the required anesthesia for the procedure 11. Patients on testosterone replacement therapy 12. Patients unable to hold blood thinners, or with coagulation related issues 13. Patients currently taking medication for BPH (eg. Alpha-blockers or 5-ARIs) who are unwilling or unable to discontinue (washout) prior to treatment (14 days for α-blockers (tamsulosin, alfuzosin, silodosin, doxazosin, terazosin), 8 weeks for finasteride, 5 months for dutasteride) 14. Diagnosis of Hidradenitis suppurativa