FDA grants 510(k) clearance to AI-powered robotic system for Aquablation therapy

The FDA has granted 510(k) clearance to the HYDROS robotic system, an AI-powered platform designed to enhance the delivery of Aquablation therapy for patients with benign prostatic hyperplasia (BPH), PROCEPT BioRobotics, the developer of the platform, announced in a news release.¹

The safety and efficacy of the Aquablation procedure were established in the WATER I and WATER II clinical trials.

“We are pleased to bring the HYDROS Robotic System to the US market,” said PROCEPT BioRobotics CEO Reza Zadno in the news release.¹ “This milestone marks a pivotal moment for PROCEPT as Aquablation therapy continues its rapid adoption, with over 400 robotic systems now installed across the United States. After years of research and development, HYDROS introduces significant technological advancements designed for mass-market adoption, and we believe will power the next phase of our growth.”

According to the company, key features of the HYDROS robotic system include FirstAssist AI treatment planning, advanced image guidance, robotic resection, and a streamlined workflow. FirstAssist AI is built on data from over 50,000 real-world Aquablation procedures and uses image recognition software to provide an optimal treatment plan for each patient. The system integrates both ultrasound and cystoscopy images to offer a multidimensional view of the entire prostate, which can enable individualized treatment planning based on patients’ anatomy.

A full market release of the HYDROS System is expected within the current quarter, with immediate availability to hospitals across the United States, according to PROCEPT.

Data on Aquablation

The safety and efficacy of the Aquablation procedure were established in the WATER I (NCT02505919) and WATER II (NCT03123250) clinical trials.

In the pivotal WATER I study, which supported Aquablation’s FDA clearance in 2017,² Aquablation demonstrated superior safety and noninferior efficacy compared with transurethral resection of the prostate (TURP) in patients with prostates ranging from 30 mL to 80 mL.³

The primary safety end point for the study was met at 3-month follow-up, with Aquablation demonstrating a lower event rate (Clavien-Dindo persistent Grade 1 or Grade 2 or higher operative complications) vs TURP (26% vs 42%; P = .0149 for superiority).

Further, the study’s primary efficacy end point of a reduction in International Prostate Symptom Score (IPSS) was achieved at 6 months, with a mean IPSS decrease of 16.9 points from baseline for Aquablation compared with 15.1 points for TURP. (P < .0001 for non-inferiority; P = .1346 for superiority). At the study’s final follow-up at 5 years, patients in the Aquablation arm had experienced an average IPSS improvement of 15.1 points, vs 13.2 points in the TURP arm (P = .2764).

Aquablation also demonstrated superior safety and efficacy vs TURP in a subgroup of patients with prostates over 50 mL. In this group, the IPSS reduction was 3.5 points greater across all follow-up visits with Aquablation compared with TURP (P = .0123). The study also showed a 51% lower risk of retreatment due to recurrent lower urinary tract symptoms at 5 years in the Aquablation arm vs the TURP arm.

In total, the prospective WATER I trial included 181 patients across 17 clinical trial sites in the United States, United Kingdom, Australia, and New Zealand. Patients enrolled in the trial had moderate to severe lower urinary tract symptoms secondary to BPH.

The WATER II trial was a prospective, multicenter clinical trial that demonstrated the safety and efficacy of Aquablation in patients with prostates ranging from 80 mL to 150 mL.⁴ In total, the trial enrolled 101 patients across 16 clinical trial sites in the United States and Canada.

The study met its primary safety and efficacy end points at 3 months, which were the incidence of Clavien-Dindo adverse events and the change in total IPSS from baseline, respectively. At the study’s final follow-up, the average IPSS improved from 22.6 at baseline to 6.8 (P < .001) at 5 years. The average maximum urinary flow rate also improved from 8.6 mL/s at baseline to 17.1 mL/s at 5 years (P < .001). Further, 96.3% of patients were free from a secondary BPH procedure at 5 years, per Kaplan-Meier estimates.

“As a urologist, my goal is to treat my patients’ symptoms while preserving their quality of life. Aquablation therapy has been instrumental in helping me achieve this for patients struggling with BPH,” said Steven A. Kaplan, MD of the Icahn School of Medicine at Mount Sinai in New York, New York.¹ “The HYDROS Robotic System advances this further by utilizing the power of AI to better read and interpret ultrasound for optimal surgical planning.”

References

1. PROCEPT BioRobotics announces FDA clearance of the HYDROS robotic system, the next-generation, AI-powered platform for Aquablation therapy. News release. PROCEPT BioRobotics. Published online and accessed August 21, 2024. https://ir.procept-biorobotics.com/news-releases/news-release-details/procept-biorobotics-announces-fda-clearance-hydrostm-robotic

2. Reimbursement for Aquablation Therapy. PROCEPT BioRobotics. Accessed August 21, 2024.

https://www.procept-biorobotics.com/aquabeam-surgical-robotic-system/reimbursement/#:~:text=Aquablation%20Therapy%20is%20a%20Benign,national%20and%20regional%20insurance%20payers.

3. Gilling PJ, Barber N, Bidair M, et al. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022;29(1):10960-10968

4. Bhojani N, Bidair M, Kramolowsky E, et al. Aquablation therapy in large prostates (80-150 mL) for lower urinary tract symptoms due to benign prostatic hyperplasia: Final WATER II 5-year clinical trial results. J Urol. 2023;210(1):143-153. doi:10.1097/JU.0000000000003483