BPH surgical robot granted FDA de novo request
The FDA has granted a de novo request for PROCEPT BioRobotics’ AquaBeam System for the resection and removal of prostate tissue for the treatment of lower urinary tract symptoms (LUTS) as a result of BPH. The system, which delivers Aquablation therapy, is the first FDA granted surgical robot providing autonomous tissue removal for the treatment of BPH, according to the company. 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, 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. The system will be commercially available in the U.S. in early 2018.
For more information, visit www.procept-biorobotics.com.