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Microwave Ablation System Bd-Gt
Betters (Suzhou)Medical Co., Ltd.
Product: Betters (Suzhou)Medical Co., Ltd. — all models and sizes
Summary: The microwave ablation system BD-GT by Betters(Suzhou) Medical is a device used for tumor ablation. It has been FDA cleared and is supported by 11 studies. Key evidence highlights its use in treating malignant tumors with CT guidance.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K232240 ↗
Decision Date ?
November 13, 2023
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The microwave ablation system BD-GT was cleared by the FDA through the 510(k) pathway on November 13, 2023. It is manufactured by Betters(Suzhou) Medical and classified as a Class 2 device.
What It Is
The microwave ablation system BD-GT is designed to deliver microwave energy to ablate tumor tissues. It is primarily used in interventional oncology for the treatment of malignant tumors, leveraging microwave technology to induce thermal destruction of cancerous cells.
FDA-Cleared Indications
- Microwave ablation of tumor tissue using a percutaneous or surgical approach.
- Use with imaging guidance, such as computed tomography, ultrasound, or other appropriate imaging, to position the ablation applicator.
- Treatment of malignant tumors when thermal ablation is clinically appropriate.
Clinical Applications
- Image-guided percutaneous ablation of selected liver tumors.
- Image-guided ablation of selected lung tumors.
- Image-guided ablation of selected thyroid tumors.
- Treatment of localized tumors in patients who are not candidates for, or prefer an alternative to, resection when the treatment is consistent with the device labeling and clinical judgment.
Reported off-label uses
- Ablation of selected benign tumors, depending on tumor location, size, symptoms, and available clinical evidence.
- Ablation of selected tumors in other organs, such as kidney or bone, where microwave ablation is used in clinical practice but the specific use may not be included in this device's FDA labeling.
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 available literature includes 11 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2020 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the microwave ablation system BD-GT is effective in achieving tumor necrosis in liver and thyroid cancers. The device has shown promising results in reducing tumor size and improving patient outcomes, particularly in cases where surgical options are limited.
Safety Profile
Reported complications include minor thermal injuries and transient pain at the ablation site. Overall, the safety profile is favorable, with most adverse events being manageable and non-life-threatening.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term efficacy and safety, as well as to explore its use in a broader range of tumor types.
Practical Considerations
- Applicator sizes, shaft lengths, active-tip lengths, and available configurations should be confirmed in the current manufacturer instructions for use; these determine access options and the size and shape of the ablation zone.
- The system is typically used with CT or ultrasound guidance, and treatment planning should account for nearby bowel, major vessels, bile ducts, airways, nerves, and other heat-sensitive structures.
- MRI compatibility should not be assumed. Confirm the system and each accessory's MR Safe, MR Conditional, or MR Unsafe status before bringing any component into the MRI environment.
- Treatment is generally performed with local anesthesia and moderate sedation or general anesthesia, depending on tumor location, patient factors, and whether the approach is percutaneous or surgical.
- Contraindications and precautions may include inability to safely access the target, uncorrected bleeding risk, active infection, and conditions that make anesthesia or thermal ablation unsafe.
Frequently Asked Questions
What are the clinical indications for microwave ablation system bd-gt?
The device is indicated for the ablation of malignant tumors, including those in the liver, thyroid, and lungs.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective tumor necrosis and size reduction, with improved patient outcomes in non-surgical candidates.
What complications have been reported?
Safety data indicate minor thermal injuries and transient pain as the most common complications, with a generally favorable safety profile.
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.