What is High Intensity Focused Ultrasound (HIFU)?
High Intensity Focused Ultrasound (HIFU) is an innovative, non-invasive technology that uses focused ultrasound waves to generate therapeutic effects in targeted tissues. Much like how a magnifying glass can focus light to create heat, HIFU concentrates ultrasound energy onto a specific area, raising the temperature to induce controlled thermal destruction. This technology allows precise targeting of tissues, sparing surrounding areas and reducing the risks associated with more invasive procedures.
The Neurolyser XR utilizes High Intensity Focused Ultrasound (HIFU) technology to achieve precise thermal ablation of neural tissue at the bone tissue interface. This state-of-the-art system combines fluoroscopic guidance with HIFU, allowing for accurate targeting and effective ablation of the lumbar medial branch nerves, thereby reducing pain and improving patient outcomes.
HIFU Technology and Design
Non-Invasive Therapy
Unlike traditional radio-frequency ablation, the Neurolyser XR does not require the insertion of needles or cannulas, eliminating the risks associated with invasive procedures such as infection, bleeding, and patient discomfort.
Precision Targeting
The system integrates with fluoroscopy or X-ray guidance to ensure precise localization of the targeted nerves, enhancing the accuracy and effectiveness of the treatment.
Reduced Procedure Time
The Neurolyser XR simplifies the treatment process, potentially reducing procedure time and associated healthcare costs while maintaining high standards of care.
Enhanced Patient Experience
Patients benefit from a non-invasive treatment that involves less pain, shorter recovery times and rapid pain relief, improving overall satisfaction and quality of life.
Key Features
Key Features
Principle of Operation: Ablating the Soft Tissue-Bone Interface
01
Focused Ultrasound Energy
The Neurolyser XR uses multiple ultrasound beams directed to converge at a precise focal point within the body. This treatment point is carefully selected to include the area where the nerve tissue is close to a bone.
02
High Acoustic Absorption of Bone
Bone has a higher acoustic absorption rate compared to soft tissue. When the ultrasound waves reach the bone-tissue interface, the bone absorbs the energy more efficiently, leading to a localized increase in temperature.
03
Thermal Ablation
The elevated temperature at the focal point causes thermal ablation of the targeted neural tissue. This process effectively disrupts the pain signals being transmitted by the nerve, providing rapid relief from chronic pain.
04
Controlled Treatment
By precisely controlling the ultrasound energy and focusing it on the bone-tissue interface, the Neurolyser XR can create a thermal lesion in the targeted area while minimizing the impact on surrounding tissues. This precise targeting is facilitated by real-time imaging and the system’s advanced positioning apparatus.
05
Safety Features
The Neurolyser XR includes multiple safety mechanisms, such as real-time feedback, an initial verification pulse to verify targeting, and continuous verbal interaction with the patient, all extra measurements to ensure accurate targeting and patient safety throughout the procedure.
The Neurolyser XR system is comprised of several components:
Control Unit: Generates and controls the electrical pulses driving the high-intensity transducer.
Positioner and Aiming Apparatus: Ensures the transducer is correctly positioned above the patient’s back and maintains its position throughout the procedure.
Ultrasonic Transducer: Delivers focused ultrasound energy to the targeted neural tissue, creating a thermal lesion without penetrating the skin.
Imaging Workstation: Provides real-time image processing and analysis to assist physicians in achieving accurate transducer placement and effective treatment in less time and radiation exposure.
Gel Pad: Ensures efficient acoustic coupling between the transducer and the patient’s body.
The Neurolyser XR
Indications for Use
The Neurolyser XR is indicated for the thermal ablation of neural tissue to relieve pain from lumbar facet joint arthritis. It is suitable to be used by interventional pain management physicians trained in the equivalent RFA procedure and familiar with its clinical applications and associated risks.
The Neurolyser XR is approved in Europe for neurotomy of the lumbar medial branch nerve as a treatment for facet arthritis low back pain.
Previous clinical studies and publications:
The Neurolyser XR have been through multiple clinical trials, details of which can we found in the ClinicalTrials.gov website.
Peer reviewed publications of the pre-clinical and clinical studies are available here
The Neurolyser XR is indicated for thermal ablation of the neural tissue (neurolysis), where the medial branch nerve of the lumbar facet joints is located.
It is suitable to be used by interventional pain management physicians trained in the equivalent RFA procedure and familiar with its clinical applications and associated risks.
The Neurolyser XR is approved in Europe, UK and Canada for neurolysis of the lumbar medial branch nerve as a treatment for facet arthritis low back pain.
The Neurolyser XR is not approved in the USA.
Previous clinical studies and publications:
The Neurolyser XR have been through multiple clinical trials, details of which can we found in the ClinicalTrials.gov website.
Peer reviewed publications of the pre-clinical and clinical studies are available here