REDWOOD SHORES, Calif.--(BUSINESS WIRE)--PROCEPT BioRobotics, a Silicon Valley surgical robotics company developing novel and disruptive technologies to treat prostate disease, announced that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the company’s AQUABEAM® System for the resection and removal of prostate tissue for the treatment of lower urinary tract symptoms (LUTS) as a result of benign prostatic hyperplasia (BPH), or enlarged prostate.
The AQUABEAM System, delivering Aquablation therapy, is the first FDA granted surgical robot providing autonomous tissue removal for the treatment of BPH. Aquablation therapy is the only treatment for BPH that combines the following three key elements to remove prostate tissue safely, quickly and precisely:
1. The clarity of real-time, multi-dimensional imaging for improved decision-making and treatment planning
2. The accuracy of an autonomous robot for precise treatment execution according to the surgeon’s plan
3. The power of a heat-free waterjet, which eliminates the possibility of complications arising from thermal injury
The AQUABEAM System’s commercial access to the U.S. market was supported by the results of the global WATER (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) study, a 181-patient, double-blind, randomized clinical trial comparing Aquablation therapy with the AQUABEAM System with Transurethral Resection of the Prostate (TURP) for the treatment of LUTS caused by BPH. When compared to TURP, the surgical gold standard, Aquablation therapy demonstrated equivalent efficacy outcomes with a superior safety profile, including a reduction in sexual side effects by a ratio of four to one.
“Until today, with current BPH treatment options, men have had to choose between significant symptom relief with a high risk of sexual side effects or a lower risk of sexual complications with less than adequate symptomatic benefit. For this reason, many men have avoided treatment altogether,” said Co-Principal Investigator Claus Roehrborn, M.D., Chair of the Department of Urology at University of Texas, Southwestern in Dallas. “Aquablation therapy breaks this trade-off in favor of the patient. Men can now benefit from significant symptom improvement alongside a low risk of sexual complications.”
Additional data from the WATER study demonstrated that Aquablation therapy resulted in statistically superior symptom improvements compared to TURP in a pre-specified subgroup analysis of men with larger prostate volumes.
