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vivaring microwave ablation probe
Vivant Medical
Summary: The Vivaring Microwave Ablation Probe is a device used for tumor ablation, primarily in lung and liver cancers. Key evidence highlights its effectiveness in creating precise ablation zones, though predicting these zones remains challenging.
FDA Clearance Information
Pathway 510K
Number K040279 ↗
Decision Date March 2, 2004
Product Code GEI
Device Class Class 2
Evidence 0 studies
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
The Vivaring Microwave Ablation Probe is a medical device designed to ablate tumors using microwave energy. It generates electromagnetic waves to heat and destroy cancerous tissues, primarily used in lung and liver cancer treatments.
Clinical Applications
Commonly used in the treatment of early-stage lung cancer and hepatocellular carcinoma, the device is applied in scenarios where surgical options are limited or inoperable. It is also used for palliating malignant central airway obstructions.
Evidence Summary
The literature includes 10 studies, comprising pilot studies and clinical trials, conducted between 2021 and 2024. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the Vivaring Microwave Ablation Probe effectively creates ablation zones in tumor tissues, with variations depending on probe configuration. It shows promise in treating early-stage lung cancer and hepatocellular carcinoma.
Safety Profile
Reported complications include pleura-related issues such as pneumothorax, particularly in lung cancer treatments. The safety profile is generally favorable, with ongoing evaluations of procedural risks.
Evidence Limitations
Current evidence highlights challenges in predicting ablation zone geometry accurately. Further research is needed to optimize probe configurations and improve procedural outcomes, especially in complex anatomical regions.
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.
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.