AquaBeam System for BPH Treatment

The world’s first commercially available autonomous tissue removal robot for the treatment of BPH.

Next-Generation Technology

The AquaBeam System, delivering Aquablation therapy, couples sophisticated design with high-tech autonomous robotics, allowing more surgeons to help a wider range of patients get optimal results.

Regardless of prostate anatomy, resection times are short and consistent, paving the way for greater procedural predictability.

The Aquablation Procedure

Aquablation therapy with the AquaBeam System is an intuitive procedure allowing for an individualized prostate resection.

Real-time, Multi-dimensional Imaging

Unlike traditional surgical BPH methods, Aquablation therapy combines an integrated cystoscope with intra-operative ultrasound, providing the surgeon with more information for improved decision making and treatment planning.

Real-time, Multi-dimensional Imaging

Unlike traditional surgical BPH methods, Aquablation therapy combines an integrated cystoscope with intra-operative ultrasound, providing the surgeon with more information for improved decision making and treatment planning.

Personalized Treatment Planning

Visualizing the prostate in multiple views on the AquaBeam System monitor, the surgeon maps the exact treatment contour, personalizing the optimal tissue removal plan for each individual patient.

Using the transverse and sagittal ultrasound views of the prostate, the surgeon easily adjusts the length, sweep angle and depth of treatment, defining the three-dimensional boundary for prostate tissue resection, while sparing the anatomical landmarks responsible for continence and ejaculatory function.

Personalized Treatment Planning

Visualizing the prostate in multiple views on the AquaBeam System monitor, the surgeon maps the exact treatment contour, personalizing the optimal tissue removal plan for each individual patient.

Using the transverse and sagittal ultrasound views of the prostate, the surgeon easily adjusts the length, sweep angle and depth of treatment, defining the three-dimensional boundary for tissue resection, while sparing the anatomical landmarks responsible for continence and ejaculatory function.

Heat-free Waterjet with Autonomous Robotic Execution

Once treatment planning is complete, the surgeon monitors with confidence as the AquaBeam System autonomously executes the treatment plan, resecting the identified prostate tissue with a heat-free, high-velocity waterjet.

Using the surgeon-defined treatment contour, the AquaBeam System software calculates the various flow-rates based on the length, depth, and width of resection required.

Based on the WATER Study results, resection times are consistent regardless of prostate size.

Heat-free Waterjet with Autonomous Robotic Execution

Once treatment planning is complete, the surgeon monitors with confidence as the AquaBeam System autonomously executes the treatment plan, resecting the identified prostate tissue with a heat-free, high-velocity waterjet.

Using the surgeon-defined treatment contour, the AquaBeam System software calculates the various flow-rates based on the length, depth, and width of resection required.

Based on the WATER Study results, resection times are consistent regardless of prostate size.

Clinical Data

Randomized to the surgical gold-standard TURP, Aquablation therapy with the AquaBeam System met its primary clinical endpoints demonstrating superior primary safety (3 months) and non-inferior primary efficacy (6 months) results. The WATER Study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue) is a double-blind, prospective, randomized clinical trial, conducted under U.S. investigational device exemption (IDE).

WATER Study Data

The initial results from the WATER Study (prostates size 30 to 80 mL) were presented at the American Urological Association (AUA) Annual Meeting in Boston, on May 14, 2017. View the presentation

Primary Safety – 3 Months

The 3-month primary safety endpoint rate was lower in the Aquablation group compared to TURP (26% vs. 42%, p=.0149) demonstrating superiority.

p<0.02
Aquablationsuperior to TURP
p<0.01
p=NS
Aquablationsuperior to TURP
p<0.02
p<0.01
p=NS

The rate of persistent grade 1 events at month 3 was lower (7% vs. 25%, p=.0004) after Aquablation and the rate of grade 2 and above events was similar across groups (20% for Aquablation vs. 23% for TURP, p=.3038). The safety results held consistent at 6 months.

* Occurrence of complications graded using the Clavien-Dindo (CD) system rated as grade 2 or higher or persistent grade 1
** CD1P incontinence, erectile dysfunction, and ejaculatory dysfunction. CD2+ events requiring pharmacological treatment, blood transfusions, endoscopic, surgical or radiological interventions, or potentially life-threatening conditions

Primary Efficacy – 6 Months

Aquablation therapy showed comparable efficacy outcomes (non-inferior) to the gold standard TURP.

TURP
Aquablation therapy
Aquablationnon-inferior to TURP
All Patient
p=0.1

Pre-specified Subgroup Analysis – Larger Prostates

Superior symptom improvements in men with larger prostates. Aquablation therapy resulted in statistically superior symptom improvements compared to TURP in a pre-specified subgroup analysis of men with larger prostate volumes (between 50 and 80 mL).

TURP
Aquablation therapy
Aquablationsuperior to TURP
Subgroup 50-80 mL prostates
p=0.01

Summary

Aquablation therapy showed a superior safety profile with very strong efficacy outcomes comparable to TURP

  • 100% of Aquablation patients improved IPSS at six months compared to baseline
  • 90% of Aquablation patients improved IPSS by 50% or more at six months
  • Superiority in IPSS improvement with Aquablation therapy in men with prostate volume greater than 50 mL as compared to TURP (p<0.01) through six months
  • A significantly lower rate of ejaculatory dysfunction among sexually active men (1 to 4 ratio, p=0.001) as compared to TURP at six months. In sexually active men with prostate volume greater than 50 mL, ejaculatory dysfunction was significantly less common after Aquablation (2%) vs. TURP (41%), p=0.0001
  • Improved incontinence severity scores (ISI) at six months
  • Superiority in overall sexual satisfaction as compared to TURP at six months

Risk and Safety Information
The AQUABEAM System is indicated for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms due to benign prostatic hyperplasia. The System is contraindicated for patients diagnosed with or suspected to have cancer of the prostate. Possible risks and complications include, but are not limited to, bleeding, discomfort and pain, dysuria, incontinence, urinary tract infection and anejaculation.* There is a low risk of injury to the urethra or rectum where the devices gain access to the body for treatment.

* Gilling P. et al. “WATER – A Double-Blind Randomized Controlled Trial of Aquablation vs. TURP” J Urol. January 2018.

“With the results in the TURP cohort providing a very strong control group, the WATER Study was able to demonstrate that Aquablation achieves comparable overall outcomes for the subjective and objective efficacy measures with even better results in larger glands.”

Dr. Roehrborn
WATER Study Co-Principal Investigator
UT Southwestern, Dallas, Texas

Resources

Faysal Yafi, MD Aquablation outcomes for the U.S. cohort of men with LUTS due to BPH in large prostates (80-150 cc) International Journal of Impotence Research Jul 2018
Peter Gilling, MD Aquablation for Benign Prostatic Hyperplasia Journal of Videourology Jan 2017
Catriona MacRae, MBBS How I Do It: Aquablation for the prostate using the AquaBeam system Candadian Journal of Urology Dec 2016
Marie Adrianne Pimentel Aquablation: Early Clinical Results Current Bladder Dysfunction Reports Mar 2016

Instruction for Use

The following Instructions for Use are for the United States only. For country-specific Instructions for Use, please contact cs@PROCEPT-BioRobotics.com.

PROCEPT BioRobotics is pleased to support providers seeking reimbursement for Aquablation therapy.

The Aquablation Reimbursement Center (ARC) provides individual reimbursement assistance to providers. This HIPAA-secured customer service center offers:

  • Answers to general questions about coding, coverage and payment
  • Submission for prior authorization
  • Facilitation of claims appeal submission

 

Select from the links below to download additional reimbursement resources:

Hours: Monday-Friday 10AM – 5PM CT
Email and Voice Mail messages returned within one business day
Email: reimbursement@Aquablation.us
Phone: 833 230 2406
Fax: 650 649 1856

To request assistance with reimbursement questions or prior authorization, please contact us through secure email, fax, or phone.

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Disclaimer: The information provided through this webpage was obtained from third-party sources and is subject to change without notice as a result of changes in reimbursement laws, regulations, rules, policies, and payment amounts. All content is informational only, general in nature, and does not cover all situations or all payers’ rules and policies. It is the responsibility of the hospital or physician to determine appropriate coding for a particular patient and/or procedure. Any claim should be coded appropriately and supported with adequate documentation in the medical record. A determination of medical necessity is a prerequisite that PROCEPT BioRobotics assumes will have been made prior to assigning codes or requesting payments. Any codes provided are examples of codes that specify some procedures or which are otherwise supported by prevailing coding practices. They are not necessarily correct coding for any specific procedure using PROCEPT BioRobotics products.

Hospitals and physicians should consult with appropriate payers, including Medicare Administrative Contractors, for specific information on proper coding, billing, and payment levels for healthcare procedures. PROCEPT BioRobotics makes no express or implied warranty or guarantee that (i) the list of codes and narratives available through these resources is complete or error-free, (ii) the use of this information will prevent difference of opinions or disputes with payers, (iii) these codes will be covered [or (iv) the provider will receive the reimbursement amounts set forth herein]. Reimbursement policies can vary considerably from one region to another and may change over time.

Accessory Products

PROCEPT BioRobotics is dedicated to developing products and accessories designed to streamline the Aquablation procedure and improve the patient’s experience during and following BPH surgery.

Catheter Tensioning Device (CTD)

The CTD is a custom catheter tensioning device designed for comfortably and reliably securing the urinary catheter for post-operative irrigation and hemostasis. The device is commercially available in the U.S., Europe, Canada, Australia and New Zealand.

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