đź“Š Evidence-Based Reference
Microwave Ablation System
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Product: Dophi — all models and sizes
Summary: The Surgnova microwave ablation system is used for tumor ablation, particularly in liver and thyroid cases. Key evidence highlights its efficacy and safety in stereotactic and overlapping ablation techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K183153 ↗
Decision Date ?
July 8, 2019
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The Surgnova microwave ablation system was cleared by the FDA via the 510(k) pathway on July 8, 2019. It is manufactured by Surgnova Healthcare Technologies and classified as a Class 2 device.
What It Is
The microwave ablation system by Surgnova is designed for the thermal ablation of tumors using microwave energy. It is intended for use in the treatment of primary and secondary liver tumors, as well as benign thyroid nodules.
FDA-Cleared Indications
- Thermal ablation of primary liver tumors.
- Thermal ablation of metastatic liver tumors.
- Thermal ablation of benign thyroid nodules.
Clinical Applications
- Percutaneous microwave ablation of selected primary liver tumors.
- Percutaneous microwave ablation of selected metastatic liver tumors.
- Image-guided ablation of benign thyroid nodules.
- Treatment of selected tumors when surgical resection is not appropriate, when consistent with the device labeling and the treating clinician's judgment.
Reported off-label uses
- Microwave ablation of renal tumors.
- Microwave ablation of lung tumors.
- Microwave ablation of adrenal or bone tumors.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies ranging from 2020 to 2025, encompassing various study designs such as RCTs and observational studies. These studies collectively evaluate the device's efficacy and safety.
Reported Outcomes
Published studies report that the microwave ablation system achieves high primary technique efficacy in liver tumor ablation. The device is noted for its precise ablation zone prediction and effective temperature distribution, contributing to successful tumor ablation.
Safety Profile
Reported complications include minor procedural complications, with no significant adverse events noted in the majority of studies. The device's safety profile is generally favorable, with low incidence of severe complications.
Evidence Limitations
The evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to evaluate long-term outcomes and to compare the device's performance with other ablation technologies.
Practical Considerations
- The system uses a microwave generator and one or more compatible microwave ablation applicators; applicator diameter, active tip length and shaft length vary by model.
- Treatment planning depends on tumor size, shape, location, nearby blood vessels and heat-sensitive structures. Multiple overlapping ablations may be required for larger or irregular lesions.
- The applicator is generally placed percutaneously under ultrasound, CT or another appropriate imaging modality, with local anesthesia and sedation or general anesthesia selected according to the procedure.
- MRI safety and conditional-use status must be confirmed for the specific generator, applicator and accessories. Do not assume the system or an applicator is safe in the MRI environment.
- Contraindications and precautions may include inability to safely access the target, uncorrected bleeding risk, active infection, proximity to critical structures and patient-specific anesthesia risks. The current FDA-cleared labeling and manufacturer instructions should be reviewed before use.
Frequently Asked Questions
What are the clinical indications for the microwave ablation system?
The device is indicated for the ablation of primary and secondary liver tumors and benign thyroid nodules.
What outcomes have been reported in clinical studies?
Studies report high efficacy in achieving complete tumor ablation with precise control over ablation zones.
What complications have been reported?
Safety data indicate minor procedural complications, with a low incidence of severe adverse events.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.