Procept BioRobotics said today that it won de novo clearance from the FDA for its Aquabeam device for treating benign prostate hyperplasia, saying it plans to have the device on the U.S. market early next year.
Redwood Shores, Calif.-based Procept said the federal safety watchdog used the 181-patient Water study to inform its decision. The trial, comparing Aquablation with transurethral resection of the prostate, showed equivalent efficacy and a better safety profile, including a reduction in sexual side effects by a ratio of four to one.
“FDA granted the de novo request just two years after treating the first patient in our U.S. pivotal trial. This is a remarkable achievement, and I congratulate our talented and dedicated team of employees, physicians and researchers, and everyone who worked tirelessly to make this significant milestone for our organization possible,” CEO Nikolai Aljuri said in prepared remarks. “We believe Aquablation therapy is poised to fundamentally transform the way physicians treat men suffering from BPH.”
“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,” added co-principal investigator Dr. Claus Roehrborn of the 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.”
“The Aquabeam system allows surgeons to determine an optimal tissue removal plan for each individual patient and achieve predictable, reproducible results, even in the case of larger prostates and prostates with obstructive median lobes,” noted co-principal investigator Dr. Peter Gilling of the University of Auckland, Bay of Plenty Clinical School Tauranga. “Additionally, the easy-to-use system coupled with autonomous robotic resection paves the way to the future of surgery by enabling consistent results, independent of surgeon experience.”