FDA grants De Novo authorization for the AquaBeam robot to treat enlarged prostate

PROCEPT BioRobotics/HYDROS Robotic System (Aquablation)

The FDA authorized PROCEPT's AquaBeam system through the De Novo route, which creates a new device category, for urinary symptoms caused by an enlarged prostate. It combines live imaging, a robot that carries out the surgeon's plan, and a heat-free waterjet. The decision rested on the 181-patient WATER trial against the standard surgery, TURP.

• First FDA authorization for robotic waterjet prostate tissue removal.
• WATER trial: 181 patients, randomized and double-blind versus TURP.
• Similar symptom relief to TURP, with sexual side effects cut by roughly four to one.
• US commercial launch followed in early 2018.