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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 510K
Number K072687 ↗
Decision Date November 25, 2008
Product Code NEY
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.
Clinical Applications
This device is commonly used in clinical scenarios involving the ablation of liver tumors and other solid tumors. It is particularly useful in cases where surgical resection is not feasible or as an adjunct to other cancer therapies.
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.
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.