Exploring Robotic Aquablation Therapy with PROCEPT BioRobotics’ Hydros System

At the forefront of medical technology, the latest advancements are changing the treatment of common prostate conditions like benign prostatic hyperplasia (BPH) and prostate cancer. As part of our commitment to keeping you informed about the most innovative developments in healthcare, we’re spotlighting the PROCEPT BioRobotics Hydros system, a next-generation robotic platform for Aquablation therapy. This technology combines artificial intelligence (AI), real-time imaging, and robotic precision to deliver an advanced, minimally invasive treatment option. With the recent FDA clearance of the Hydros system in 2024, this breakthrough could change the way we treat prostate conditions.

What is Aquablation Therapy?

Aquablation therapy is a minimally invasive procedure designed to treat BPH by removing excess prostate tissue with a high-velocity waterjet. Unlike traditional heat-based procedures like transurethral resection of the prostate (TURP), which can damage surrounding tissue, Aquablation uses heat-free resection, minimizing the risk of complications such as erectile dysfunction or incontinence. This precision-based approach targets the overgrown tissue while preserving critical structures involved in sexual and urinary function.

BPH affects millions of men globally, causing uncomfortable symptoms like frequent urination and weak urinary flow. Left untreated, it can lead to more severe complications, such as urinary retention or kidney damage. Aquablation therapy offers a compelling solution by providing long-term symptom relief with minimal side effects, according to PROCEPT BioRobotics’ robust clinical data. The procedure has shown remarkable success rates, with 94% of patients avoiding re-treatment over a five-year period and 89% preserving ejaculatory function post-surgery.

Comparing Traditional Aquablation and Robotic Aquablation

While Aquablation therapy has been a game-changer for BPH treatment, the introduction of the Hydros robotic system from PROCEPT BioRobotics elevates the procedure by incorporating robotics and AI, enhancing the surgeon's ability to deliver a precise and personalized treatment plan. Here’s how traditional Aquablation differs from the new robotic version:

Traditional Aquablation

In traditional Aquablation therapy, the procedure is manually guided by the surgeon with the help of ultrasound imaging. While highly effective, this version of the procedure relies on the surgeon’s expertise and manual control throughout the waterjet resection process. The real-time ultrasound imaging provides a clear view of the prostate, but the surgeon must interpret the imaging data and guide the procedure manually, which can lead to variability in outcomes depending on the surgeon’s skill and experience.

Robotic Aquablation with the Hydros System

In contrast, the Hydros system integrates AI-powered treatment planning and robotic precision to automate many aspects of the procedure. The Hydros system’s FirstAssist AI uses data from over 50,000 procedures to help the surgeon create an optimized, patient-specific treatment plan. This AI-assisted approach identifies critical structures and offers suggestions on how to perform the resection, taking a significant amount of guesswork out of the process.

With robotic resection, the system executes the treatment plan with unparalleled accuracy. The surgeon can focus on overseeing the procedure rather than controlling every movement, resulting in a more consistent and precise outcome. Additionally, the dual high-definition touchscreens allow for real-time viewing of ultrasound and cystoscopy images simultaneously, enhancing visualization and providing more control throughout the operation.

Key Differences at a Glance:

• Manual Control vs. Robotic Precision: Traditional Aquablation requires manual operation by the surgeon, while robotic Aquablation automates key aspects, leading to greater precision.
• AI Treatment Planning: Robotic Aquablation with the Hydros system uses AI to suggest the best treatment approach based on real-world data, improving consistency.
• Advanced Visualization: The Hydros system offers a multi-dimensional view of the prostate, enhancing the surgeon’s ability to tailor the procedure to the patient’s anatomy.

This combination of AI-driven insights and robotic execution sets the Hydros system apart, raising the bar for BPH treatment and creating new opportunities for the future of prostate cancer treatment.

PROCEPT BioRobotics: A Leader in Urological Innovation

Based in San Jose, California, PROCEPT BioRobotics is a medical technology company focused on developing minimally invasive solutions for urological conditions. The company’s flagship technology, Aquablation therapy, was initially designed to treat benign prostatic hyperplasia (BPH), a common condition among older men. With the recent FDA approval of their next-generation Hydros system, PROCEPT is now positioned as a leader in the robotic surgery space.

PROCEPT’s journey toward FDA clearance has been marked by rigorous clinical testing and a commitment to improving patient outcomes. In September 2023, the company received FDA investigational device exemption (IDE) approval to study Aquablation therapy for prostate cancer. The approval opened the door for the WATER IV PCa trial, which aims to compare Aquablation to radical prostatectomy for treating localized prostate cancer. If successful, Aquablation could become a first-line treatment for prostate cancer, offering a less invasive alternative to traditional surgery .

In August 2024, PROCEPT achieved another significant milestone with FDA 510(k) clearance for its Hydros robotic system. The 510(k) clearance indicates that the FDA recognizes the Hydros system as safe and effective for use in BPH treatments. The Hydros system represents the culmination of years of research and development, leveraging insights from over 50,000 Aquablation procedures to create a more efficient, precise, and AI-powered platform. According to PROCEPT’s CEO, Reza Zadno, the FDA clearance marks a pivotal moment for the company as it expands the market presence of Aquablation therapy with over 400 robotic systems now installed across the United States .

Clinical Results

The clinical data supporting Aquablation therapy continues to grow, with results from multiple studies confirming its efficacy and safety. Aquablation therapy consistently demonstrates low complication rates and durable symptom relief across a variety of patient profiles and prostate sizes:

• WATER Study: This landmark clinical trial compared Aquablation therapy to TURP, the traditional standard for BPH treatment. The study found that Aquablation therapy was superior in safety and non-inferior in efficacy, with significantly lower rates of irreversible complications like erectile dysfunction and incontinence.

• WATER II Study: Focusing on larger prostates (80-150 mL), this trial confirmed that Aquablation therapy significantly improved symptom scores and urinary flow rates, delivering best-in-class outcomes for men with large prostates.

• OPEN WATER and JAPAN PMS Studies: Both of these real-world studies validated Aquablation therapy’s effectiveness in a commercial setting. The results demonstrated the procedure’s size- and shape-independence, as well as its durable outcomes over five years.

The Future: Robotic Aquablation as a First-Line Cancer Treatment?

With the FDA-approved WATER IV PCa trial now underway, PROCEPT BioRobotics is exploring the potential of Aquablation therapy as a treatment for localized prostate cancer. The trial aims to determine whether Aquablation therapy can reduce treatment-related harm compared to radical prostatectomy. By providing a less invasive option, Aquablation could offer men a better quality of life while effectively managing prostate cancer. The trial’s long-term goal is to track oncologic outcomes over a 10-year period, further expanding the scope of Aquablation therapy beyond BPH treatment.

A Revolution in Urology

The Hydros robotic system from PROCEPT BioRobotics is redefining how we approach prostate surgery. By integrating AI-powered planning, advanced imaging, and robotic precision, the Hydros system offers a safer, more effective solution for men with benign prostatic hyperplasia (BPH). As the company continues to push the boundaries of urological care, we may soon see Aquablation therapy become a first-line treatment for prostate cancer, further cementing PROCEPT BioRobotics’ status as a leader in the field.

With the FDA clearance of the Hydros system and ongoing clinical trials exploring its broader applications, Aquablation therapy is poised to transform urological care for years to come. Stay tuned as we continue to bring you updates on this exciting technology and its impact on prostate health.

Sources:

1. Procept BioRobotics next-generation Hydros robotic system FDA clearance:

   • "Procept Biorobotics wins FDA nod to study surgical robot for treating prostate cancer." MassDevice, October 7, 2024, by Sean Whooley.
   • "FDA clears next-gen surgical robot from Procept Biorobotics." MassDevice, August 21, 2024, by Sean Whooley.

2. Clinical outcomes and efficacy of Aquablation therapy:

   • Procept BioRobotics website: "Clinical outcomes with Aquablation® therapy" and "Proven clinical results with Aquablation® therapy."

3. WATER, WATER II, OPEN WATER, JAPAN PMS clinical studies:

   • Procept BioRobotics website: "A summary of the four major studies evaluating Aquablation therapy" and "Proven clinical results with Aquablation® therapy."

4. FDA IDE for WATER IV PCa trial:

   • "Procept Biorobotics wins FDA nod to study surgical robot for treating prostate cancer." MassDevice, October 7, 2024, by Sean Whooley.