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Vivawave Microwave Ablation System
Valleylab
Summary: The Vivawave Microwave Ablation System by Valleylab is a device used for tumor ablation. It is primarily used in treating unresectable lung malignancies. Key evidence highlights its efficacy in improving patient survival.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K053535 ↗
Decision Date ?
April 27, 2006
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The Vivawave Microwave Ablation System was cleared by the FDA via the 510(k) pathway on April 27, 2006. It is manufactured by Valleylab and classified as a Class 2 device under product code NEY.
What It Is
The Vivawave Microwave Ablation System is a medical device designed for the ablation of tumors using microwave energy. It is intended for use in clinical settings to treat solid organ tumors, particularly when surgical resection is not feasible.
FDA-Cleared Indications
- Microwave ablation of unresectable lung malignancies.
- Use in clinical situations where surgical resection of the lung malignancy is not feasible.
Clinical Applications
- Percutaneous microwave ablation of selected unresectable lung tumors under imaging guidance.
- Intraoperative microwave ablation of selected lung malignancies when surgical resection is not feasible.
- Local destruction of targeted lung tumor tissue using a microwave ablation applicator.
Reported off-label uses
- Microwave ablation of selected liver tumors.
- Microwave ablation of selected kidney tumors.
- Microwave ablation of selected bone or adrenal 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 available literature includes two studies: a retrospective study on lung malignancies and a guideline study on power and time variables for microwave ablation. These studies span from 2009 to 2013.
Reported Outcomes
Published studies report that the Vivawave Microwave Ablation System is effective in improving survival rates in patients with unresectable lung malignancies. The retrospective study highlights its efficacy in a cohort of 56 patients.
Safety Profile
Reported complications include those associated with percutaneous CT-guided microwave ablation, as noted in the retrospective study. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of the primary study. Further research is needed to establish long-term outcomes and safety across diverse patient populations.
Practical Considerations
- The FDA record identifies the device category and lung-malignancy indication, but the provided record does not specify applicator lengths, shaft diameters, antenna sizes, or maximum ablation-zone dimensions.
- Treatment requires placement of a microwave applicator into or adjacent to the target under appropriate imaging guidance, commonly CT or ultrasound for percutaneous procedures.
- The system is intended for use with compatible components specified in the manufacturer’s labeling; accessories and generators should not be assumed to be interchangeable with other systems.
- Microwave ablation can injure nearby structures, including the pleura, airways, vessels, nerves, and chest wall. Patient selection and treatment planning should account for tumor location, size, and proximity to critical anatomy.
- MRI safety, including conditional use or contraindications, cannot be determined from the supplied FDA summary. Verify the current manufacturer labeling before bringing the system or any accessory into an MRI environment.
Frequently Asked Questions
What are the clinical indications for Vivawave Microwave Ablation System?
The device is indicated for the ablation of tumors, particularly in cases of unresectable lung malignancies.
What outcomes have been reported in clinical studies?
Studies have reported improved survival rates in patients with unresectable lung malignancies treated with the device.
What complications have been reported?
Complications related to percutaneous CT-guided microwave ablation have been reported, though specific adverse events were not detailed.
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.