No image
Neurolyser XR
The Neurolyser XR is intended for thermal ablation of neural tissue (neurolysis) at the bone tissue interface, using non- invasive high intensity focused ultrasound (HIFU) with X-ray guidance.
Details
Device typeNerve transcutaneous ultrasound ablation system: An assembly of devices intended to use high intensity focused ultrasound (HIFU) energy to create heat at controlled temperatures for noninvasive (transcutaneous) thermal ablation of neural tissue to treat chronic pain, typically through ablation of medial branch nerves at the bone/neural tissue interface. It is used together with a radiological image-guidance system (e.g., fluoroscopy system) and operating table, and consists of a software-based generator/control unit, imaging workstation, positioning and aiming elements (e.g., mechanical arm, cradle), and an ultrasound transducer/probe intended to be placed on the skin for transcutaneous delivery of focal heat to the target nerve.
FDA categoryHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Device ID07290019747000
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information