Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH

"The ProArc Medical Omega system is a prostatic reshaping device. The Omega System is comprised of two main components: Omega Delivery Device and Omega Implant.~The delivery system uses a diathermy electrode to perform a circular and superficial incision through the urethral wall into the prostate tissue, into which the arc-shaped permanent implant is placed. The implant is made up of commonly used surgical implantable nitinol material, coated with Parylene coating. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra."