Vivaring Microwave Ablation Probe
Vivant Medical
FDA Clearance Information
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
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
Reported Outcomes
Safety Profile
Evidence Limitations
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.