User:Aquaman2016/sandbox

The System
The  System is the first technology utilizing both water and robotics for the targeted removal of prostate tissue. The combines image guidance and robotics to deliver Aquablation, a minimally invasive waterjet ablation therapy that enables precisely controlled, heat-free removal of tissue for the treatment of lower urinary tract symptoms. The System is developed by PROCEPT BioRobotics in Redwood Shores, California.

Technology Description
The System consists of three main components: the console, the robotic handpiece, and the single-use probe. During the procedure, an ultrasound is used in concert with the single-use probe. The single-use probe is advanced through the urethra and the distal end of the handpiece is positioned in the bladder. Ultrasound images allow the operating physician to make adjustments in order to define the three-dimensional boundary for prostate resection. Once the surgical mapping is complete, the surgeon initiates the Aquablation treatment using a foot pedal. At this point, the console activates the pump that delivers a high-velocity sterile saline stream orthogonally (at a 90° angle) at various flow rates based on the depth of penetration required. During the administration of the saline, the console follows the prescribed treatment plan to precisely resect the prostate tissue in accordance with the three-dimensional contour mapped. At any time during the procedure, the operating physician has the ability to adjust or pause the ablation.

Efficacy
Pre-clinical studies were completed to assess the safety and feasibility of the System. The results of a Phase II clinical study investigating the safety and feasibility of Aquablation were presented on May 15, 2015 at the American Urological Association in New Orleans, Louisiana by Dr. Peter Gilling (Tauranga, New Zealand). The world's first ever Aquablation procedure had a 100 percent technical success rate in 21 patients and reduced symptoms demonstrated by a 15.9 point decrease in the mean International Prostate Symptom Score (IPSS) at 6 months. Improvement in urine flow was also observed with a 10.1 mL/sec increase in the peak urinary flow rate (Qmax) from 8.6 to 18.7 ml/sec. Post-operative dysuria (painful urination) was minimal and adverse events were typically mild and transient. There were no occurrences of urinary incontinence, loss of ejaculatory, erectile function in the study.

As of July 7, 2015, PROCEPT has received conditional approval from the FDA for an investigational device exemption trial to evaluate the safety and effectiveness of Aquablation. The WATER Study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) is a randomized blinded controlled clinical trial comparing the safety and effectiveness of Aquablation to transurethral resection of the prostate (TURP), for the treatment of benign prostatic hyperplasia.

Approval
The System is not available for sale in the United States.