Radiofrequency ablation (RFA) has become an established minimally invasive technique for managing select spinal tumors, often used alongside vertebral augmentation to address both the lesion and associated structural fracture risk. INVAMED's Fusion system is an intraosseous radiofrequency ablation platform designed for this application. This overview outlines the device's design concept and intended clinical role for spine and oncology teams.
What Is the Fusion RFA System?
Fusion is designed as a minimally invasive intraosseous radiofrequency ablation system intended for the treatment of spinal tumors. The system uses a percutaneous approach, delivering thermal energy directly into the targeted bony lesion through a dedicated introducer and catheter pathway, intended to ablate tumor tissue while allowing the surgical team to monitor the treatment zone.
What Are the Key Design Components?
The Fusion system is built around several components designed to support controlled, monitored ablation:
- 17-gauge introducer needle — designed for percutaneous access to the targeted vertebral lesion
- 5 French catheter — provides a pathway for advancing the ablation probe to the treatment site
- Thermal ablation probe — delivers radiofrequency energy intended to ablate the targeted tumor tissue within the bone
- Multi-level safety monitoring — the system is designed with monitoring features intended to support controlled energy delivery and help the operator track the ablation process
What Is the Intended Clinical Role of Spinal Tumor Ablation?
Intraosseous radiofrequency ablation is generally considered in the management of certain spinal tumors, including select metastatic lesions, where the goals may include local tumor control and pain palliation. RFA is frequently used as part of a combined approach alongside vertebral augmentation techniques such as vertebroplasty or kyphoplasty, addressing both the tumor and the mechanical stability of the affected vertebra in appropriately selected patients. Candidacy for RFA depends on tumor location, proximity to neural structures, and overall treatment goals, all of which are evaluated by the treating physician team.
What Should Clinical Teams Consider Before Use?
As with any thermal ablation technique near the spinal cord and nerve roots, careful preprocedural imaging and planning are essential to assess the lesion's proximity to critical neural structures. All ablation procedures carry inherent risks, including but not limited to thermal injury to adjacent structures and incomplete ablation, and the decision to proceed rests with the treating physician following the applicable Instructions for Use (IFU) and a complete clinical evaluation.
Frequently Asked Questions
What types of spinal tumors is the Fusion RFA system used for?
The system is designed for intraosseous radiofrequency ablation of spinal tumors, often used in the context of select metastatic vertebral lesions. Specific indications should be confirmed against the current IFU and evaluated by the treating physician.
Is radiofrequency ablation for spinal tumors typically combined with other procedures?
Yes, RFA is frequently used alongside vertebral augmentation techniques such as vertebroplasty or kyphoplasty in appropriately selected cases, addressing both tumor control and vertebral stability.
What about regulatory status and availability?
Device availability and regulatory status vary by country. Please contact INVAMED or your authorized local distributor for current regulatory information applicable to your region.
Related INVAMED Resources
- Neuro, Spine & Cranial Product Portfolio
- Vertebral Compression Fracture: An Overview
- Request Information from INVAMED
Medical Disclaimer: This article is provided for general informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment recommendation. It is not a substitute for consultation with a qualified healthcare professional. Product indications, availability, and regulatory status vary by country. Always refer to the official Instructions for Use (IFU) and consult a licensed physician for guidance specific to your situation. INVAMED devices are intended for use by trained healthcare professionals.