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loop microwave ablation probe
Vivant Medical
Summary: The loop microwave ablation probe by Vivant Medical is used for tumor ablation. It is FDA 510k cleared and supported by studies showing its effectiveness in hepatic tumors.
FDA Clearance Information
Pathway
510K
Number
K023311 ↗
Decision Date
April 9, 2003
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The loop microwave ablation probe was cleared by the FDA via the 510k pathway on April 9, 2003. It is manufactured by Vivant Medical and classified as a Class 2 device.
What It Is
The loop microwave ablation probe is a medical device designed for the ablation of tumors. It uses microwave energy to generate heat, effectively destroying targeted tissue. It is primarily used in oncology for the treatment of hepatic tumors.
Clinical Applications
This device is commonly used in the treatment of hepatic tumors, particularly in patients who are not candidates for surgical resection. It offers a minimally invasive option for tumor ablation.
Evidence Summary
The available literature includes three studies, ranging from 2004 to 2017, involving various study designs such as RCTs and case series. These studies explore the effectiveness of the loop microwave ablation probe in tumor treatment.
Reported Outcomes
Published studies report that the loop microwave ablation probe is effective in ablating hepatic tumors. The dual-loop design has shown promising results in creating larger ablation zones compared to traditional straight antennas. The device has been tested in both animal models and clinical settings.
Safety Profile
Reported complications include typical risks associated with ablation procedures, such as thermal injury to adjacent structures. However, specific safety outcomes were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety outcomes. Further research is needed to establish long-term efficacy and safety profiles in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the loop microwave ablation probe?
The loop microwave ablation probe is indicated for the ablation of hepatic tumors, particularly in patients who are not candidates for surgical resection.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective tumor ablation with the loop microwave probe, particularly in hepatic tumors, with larger ablation zones achieved compared to straight antennas.
What complications have been reported?
Reported complications include thermal injury to adjacent structures, which is a common risk in ablation procedures. Specific safety data were not detailed in the studies provided.
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.