đź“Š Evidence-Based Reference
Valleylab Microwave Ablation Generator
Covidien Lp, Formerly Know As Valleylab, A Divison
Summary: The Valleylab Microwave Ablation Generator, manufactured by Covidien Lp, is used for tumor ablation. It was FDA-cleared via the 510k pathway. Key evidence highlights its role in local cancer therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K072687 ↗
Decision Date ?
November 25, 2008
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The Valleylab Microwave Ablation Generator was cleared by the FDA through the 510k pathway on November 25, 2008. It is manufactured by Covidien Lp and classified as a Class 2 device.
What It Is
The Valleylab Microwave Ablation Generator is a medical device designed for the ablation of tumors using microwave energy. It is intended for use in image-guided tumor ablation procedures, providing a minimally invasive option for local cancer treatment.
FDA-Cleared Indications
- Use in conjunction with compatible microwave ablation accessories for the coagulation or ablation of soft tissue.
- Use during procedures intended to destroy targeted tumor tissue under appropriate clinical and imaging guidance.
Clinical Applications
- Image-guided microwave ablation of liver tumors.
- Percutaneous, laparoscopic, or surgical microwave ablation of selected solid tumors when used with compatible accessories.
- Local tumor ablation when surgical resection is not feasible or is not the selected treatment.
- Microwave ablation performed as part of a multidisciplinary cancer treatment plan.
Reported off-label uses
- Microwave ablation of selected renal tumors.
- Microwave ablation of selected lung 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 three studies, with types ranging from randomized controlled trials to case series. The studies span from 2015 to present, providing insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that the Valleylab Microwave Ablation Generator is effective in achieving local tumor control in various cancer types. The device has been shown to provide precise ablation with minimal damage to surrounding tissues, contributing to favorable clinical outcomes.
Safety Profile
Reported complications include minor thermal injuries and post-procedural pain, which are generally manageable. No significant adverse events have been consistently associated with the use of this device in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to compare its efficacy with other ablation technologies.
Practical Considerations
- The generator must be used with compatible microwave ablation antennas, cables, and accessories specified by the manufacturer; the generator alone does not perform tissue ablation.
- Ablation size depends on antenna design, power, treatment duration, tissue characteristics, and the distance between the antenna and nearby organs or critical structures.
- Treatment is typically planned and monitored with imaging such as ultrasound, computed tomography, or magnetic resonance imaging, depending on the procedure and institutional protocol.
- The generator and connected accessories should not be assumed to be MRI safe or conditional without verification of the exact system configuration and labeling.
- Potential contraindications and precautions include inability to safely access the target, uncorrected bleeding risk, active infection, and risk of thermal injury to adjacent organs, nerves, skin, or major vessels.
Frequently Asked Questions
What are the clinical indications for Valleylab Microwave Ablation Generator?
The device is indicated for the ablation of tumors, particularly in the liver, where surgical options are limited.
What outcomes have been reported in clinical studies?
Studies have reported effective local tumor control and minimal damage to surrounding tissues.
What complications have been reported?
Reported complications include minor thermal injuries and post-procedural pain, with no significant adverse events noted.
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.