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vivatip microwave ablation probe
Vivant Medical
Summary: The Vivatip Microwave Ablation Probe is a device used for tumor ablation. It is primarily used in the treatment of inoperable tumors. Key evidence highlights its effectiveness in creating precise ablation zones.
FDA Clearance Information
Pathway
510K
Number
K032702 ↗
Decision Date
October 3, 2003
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Vivatip Microwave Ablation Probe was cleared by the FDA through the 510(k) pathway on October 3, 2003. It is manufactured by Vivant Medical and classified as a Class 2 device under product code GEI.
What It Is
The Vivatip Microwave Ablation Probe is a medical device designed to ablate tumors using microwave energy. It generates electromagnetic waves to heat and destroy tumor tissue, providing a minimally invasive option for tumor management.
Clinical Applications
This device is commonly used in clinical settings for the treatment of inoperable tumors, including lung cancer and hepatocellular carcinoma. It is particularly useful in cases where surgical options are limited or not feasible.
Evidence Summary
The available literature includes 10 peer-reviewed studies, ranging from pilot studies to randomized controlled trials, conducted between 2021 and 2024. These studies explore various aspects of microwave ablation, including probe configuration and clinical applications.
Reported Outcomes
Published studies report that the Vivatip Microwave Ablation Probe is effective in creating precise ablation zones, which is crucial for successful tumor management. The device has shown promise in treating early-stage lung cancer and peripheral lung cancer, with studies highlighting its potential for local therapy in inoperable cases.
Safety Profile
Reported complications include pleura-related issues such as pneumothorax, particularly in lung cancer treatments. However, the device is generally considered safe when used according to guidelines, with studies emphasizing the importance of accurate probe placement to minimize risks.
Evidence Limitations
Current evidence is limited by small sample sizes and the need for further research to optimize probe configurations and improve predictive models for ablation zones. More extensive studies are needed to fully understand long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for Vivatip Microwave Ablation Probe?
The Vivatip Microwave Ablation Probe is indicated for the ablation of tumors, particularly in cases where surgical options are not viable, such as inoperable lung cancer and hepatocellular carcinoma.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective tumor ablation with precise ablation zones, particularly in early-stage lung cancer and peripheral lung cancer cases.
What complications have been reported?
Safety data from evidence indicate complications such as pneumothorax, especially in lung cancer treatments, highlighting the need for careful probe placement.
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.