Salient Characteristics Aquablation Robotic System.pdf
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- Solicitation number
- 36C24825Q0895
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This document details the Salient Characteristics for the Aquablation Robotic System, a medical device developed by PROCEPT BioRobotics for treating benign prostatic hyperplasia (BPH). The system includes an AquaBeam Aquablation System with multiple components such as sterilization trays, scopes, tray holders, and an Apogee Ultrasound Set, along with a one-year AquaCare service period. Key capabilities include high-velocity waterjet technology for non-thermal tissue removal, advanced robotic assistance with precise movements, real-time transrectal ultrasound imaging, personalized treatment planning, and a minimally invasive transurethral approach.
The document highlights the system's enhanced safety profile, with reduced risk of side effects and preservation of surrounding tissues, and emphasizes its clinical efficacy through proven outcomes and durable results. Additional features include a user-friendly interface, efficient treatment times, and quick patient recovery. The AquaBeam Robotic System is FDA-cleared and CE-marked, indicating compliance with U.S. and European health standards, and is used in healthcare institutions worldwide. This document is part of a Sources Sought Notice by the Department of Veterans Affairs for Bay Pines VAMC, seeking to identify potential qualified sources for the Aquablation Robotic System, with responses due by 12:00 PM EST on Tuesday, June 24, 2025.
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Salient Characteristics required for Surgical Service Aquablation Robotic System, Bay Pines VAHCS
Aquablation Robotic System:
The AquaBeam Robotic System, developed by PROCEPT BioRobotics, is distinguished by several key characteristics that make it an advanced and effective solution for the treatment of benign prostatic hyperplasia (BPH). Here are the salient characteristics of the AquaBeam Robotic
System.
Line Number Quantity Unit of Measure Description
0001 1 EA AQUABEAM AQUABLATION SYSTEM
INCLUDES:
-4EA VP0052 Sterilization Tray -4EA SC2000 AQUABEAM Scope -2 EA VP0067 Tray Holders, Short -1 EA VP0070 Tray Holders, Long -1 APOGEE 2300 Apogee Ultrasound Set Includes, 2 EA ECBP-1 ECBP-1 Probe
0002 1 EA AQUACARE - 1 YEAR SERVICE PERIOD
Capabilities:
1. High-Velocity Waterjet Technology
• Non-Thermal Tissue Removal: Uses a high-velocity waterjet to ablate and remove excess prostate tissue without generating heat, significantly reducing the risk of thermal injury to surrounding structures.
• Precision: The waterjet allows for precise removal of targeted tissue while preserving healthy tissue.
2. Advanced Robotic Assistance
• Automated Control: The robotic arm provides precise, controlled movements, ensuring consistent and accurate tissue removal.
• Reduced Human Error: Robotics minimize the variability and potential for error associated with manual procedures.
3. Real-Time Imaging
• Transrectal Ultrasound (TRUS) Guidance: Provides real-time, high-resolution imaging of the prostate and surrounding anatomy during the procedure.
• Visual Accuracy: Enhanced visual accuracy allows for precise mapping and targeting of the prostate tissue to be removed.
4. Personalized Treatment
• Customizable Plans: The system allows for detailed pre-procedure planning and customization based on individual patient anatomy and specific BPH characteristics.
• Adaptability: Tailored treatment plans optimize the effectiveness of the procedure for each patient.
5. Minimally Invasive Approach
• Transurethral Procedure: Performed through the urethra, eliminating the need for external incisions and reducing recovery time.
• Patient Comfort: Minimally invasive nature leads to shorter hospital stays and quicker return to normal activities.
6. Enhanced Safety Profile
• Reduced Risk of Side Effects: By avoiding thermal methods, the risk of common side effects such as erectile dysfunction and urinary incontinence is minimized.
• Preservation of Surrounding Tissues: The precision of the waterjet technology helps preserve nerves and muscles critical for urinary and sexual function.
7. Clinical Efficacy
• Proven Outcomes: Clinical studies have demonstrated significant improvements in urinary flow rates and reduction of symptoms in patients with BPH.
• Durable Results: The efficacy of Aquablation therapy is maintained over time, providing long-term relief for patients.
8. User-Friendly Interface
• Intuitive Operation: The system’s interface is designed to be user-friendly, facilitating ease of use for urologists.
• Comprehensive Training: Training programs and support are provided to ensure clinical staff can effectively operate the equipment.
9. Treatment Efficiency
• Shorter Procedure Times: The efficient nature of the system can result in shorter overall procedure times compared to traditional surgical methods.
• Quick Recovery: The minimally invasive approach typically leads to faster recovery and less postoperative discomfort.
10. Regulatory Approvals and Certifications
• FDA Clearance: The AquaBeam Robotic System is FDA-cleared for the treatment of BPH.
• CE Mark: The system is also CE-marked, indicating compliance with European health, safety, and environmental protection standards.
• Global Reach: The system is used in various healthcare institutions worldwide, reflecting its acceptance and reliability in different regulatory environments.
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