📊 Evidence-Based Reference

Vivaring Microwave Ablation Probe

Vivant Medical

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Summary: The Vivaring Microwave Ablation Probe is a device used for tumor ablation, primarily in lung and liver cancers. Key evidence highlights its effectiveness in creating precise ablation zones, though predicting these zones remains challenging.

FDA Clearance Information

Pathway ? 510(k)
Number ? K040279 ↗
Decision Date ? March 2, 2004
Product Code ? GEI
Device Class ? Class 2
Evidence ? 0 studies

The Vivaring Microwave Ablation Probe was cleared by the FDA via the 510(k) pathway on March 2, 2004. It is manufactured by Vivant Medical and classified as a Class 2 device under product code GEI.

What It Is

The Vivaring Microwave Ablation Probe is a medical device designed to ablate tumors using microwave energy. It generates electromagnetic waves to heat and destroy cancerous tissues, primarily used in lung and liver cancer treatments.

FDA-Cleared Indications

  • Microwave ablation of soft tissue using electromagnetic energy.
  • Ablation of targeted tumor tissue under image guidance.
  • Use in interventional procedures where controlled thermal destruction of tissue is indicated.

Clinical Applications

  • Image-guided thermal ablation of selected liver tumors.
  • Image-guided thermal ablation of selected lung tumors.
  • Percutaneous tumor ablation when surgical resection is not appropriate or feasible.

Reported off-label uses

  • Ablation of tumors in other soft-tissue organs, including selected kidney or adrenal tumors, depending on the specific device labeling and clinical circumstances.
  • Palliative thermal treatment of selected malignant central airway obstructions in specialized practice.

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 10 studies, comprising pilot studies and clinical trials, conducted between 2021 and 2024. These studies explore the device's efficacy and safety in various clinical settings.

Reported Outcomes

Published studies report that the Vivaring Microwave Ablation Probe effectively creates ablation zones in tumor tissues, with variations depending on probe configuration. It shows promise in treating early-stage lung cancer and hepatocellular carcinoma.

Safety Profile

Reported complications include pleura-related issues such as pneumothorax, particularly in lung cancer treatments. The safety profile is generally favorable, with ongoing evaluations of procedural risks.

Evidence Limitations

Current evidence highlights challenges in predicting ablation zone geometry accurately. Further research is needed to optimize probe configurations and improve procedural outcomes, especially in complex anatomical regions.

Practical Considerations

  • The probe is introduced into the target tissue, usually percutaneously, with ultrasound, CT, or another imaging modality used for positioning and treatment monitoring.
  • Probe length, shaft diameter, active-tip length, and power settings vary by model; confirm the specific Vivant Medical product configuration before use.
  • Microwave ablation creates a zone of thermal injury, but the final ablation zone can vary with tissue type, blood flow, probe position, power, and treatment duration.
  • MRI compatibility should not be assumed. Verify the exact model's labeling before bringing the probe into an MRI environment; procedures are commonly performed with CT or ultrasound guidance instead.
  • Contraindications and precautions may include inability to safely access the target, uncorrected bleeding risk, infection along the access route, and proximity to vulnerable structures.

Frequently Asked Questions

What are the clinical indications for Vivaring Microwave Ablation Probe?

The device is indicated for tumor ablation in early-stage lung cancer and hepatocellular carcinoma, particularly in patients who are not surgical candidates.

What outcomes have been reported in clinical studies?

Studies report effective tumor ablation with variations in ablation zones based on probe configuration, showing potential in treating lung and liver cancers.

What complications have been reported?

Safety data indicate complications such as pneumothorax in lung cancer treatments, with an overall 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.

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