Evaluation of the Safety and Efficacy of the Omega System for the Treatment of Benign Prostatic Hyperplasia
The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.
• Male ≥50 years of age
• Diagnosed with symptomatic benign prostatic hyperplasia (BPH).
• International Prostate Symptom Score (IPSS) \>13.
• Peak flow rate ≤ 12 ml/sec (with voided volume ≥ 125ml).
• Participant understands and is willing to the informed consent form.
• Prostate Volume between 30cc and 80cc.
• Prostate length ≥3cm and ≤5cm