Vivatip Microwave Ablation Probe

FDA-Cleared Indications

• Ablation of tumor tissue using microwave energy.
• Treatment of tumors in patients for whom surgical removal is not feasible or appropriate.

Clinical Applications

• Microwave ablation of selected tumors under image guidance.
• Percutaneous ablation of tumors when a minimally invasive local treatment is selected.
• Intraoperative tumor ablation when microwave energy is used during surgery.

Reported off-label uses

• Ablation of selected lung tumors.
• Ablation of selected hepatocellular carcinomas and other liver tumors.
• Ablation of selected tumors in other organs, depending on anatomy, tumor characteristics and institutional 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.

Practical Considerations

• The probe is used with a compatible microwave generator and treatment system; accessory and generator compatibility should be confirmed before the procedure.
• Probe dimensions and active-tip length affect the size and shape of the ablation zone and should be selected according to tumor size, location and the planned approach.
• Placement is typically performed with imaging guidance such as computed tomography or ultrasound, with attention to nearby bowel, bile ducts, blood vessels and other critical structures.
• MRI safety and conditional-use information should be verified from the device labeling and current manufacturer documentation; do not assume the probe or connected generator is MRI safe.
• Contraindications and precautions may include inability to safely access the target, uncorrectable bleeding risk, active infection at the access site and proximity to structures that cannot tolerate thermal injury.