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habib eus rfa
Emcision
Summary: The Habib EUS RFA is a radiofrequency ablation device used for pancreatic lesions. It is FDA-cleared and supported by studies showing feasibility in tumor microenvironment analysis and ablation outcomes.
FDA Clearance Information
Pathway
510K
Number
K150029 ↗
Decision Date
June 24, 2015
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Habib EUS RFA was cleared via the FDA 510(k) pathway on June 24, 2015. Manufactured by Emcision, it is classified as a Class 2 device under product code GEI.
What It Is
The Habib EUS RFA is a device designed for endoscopic ultrasound-guided radiofrequency ablation. It is used to ablate pancreatic lesions, offering a minimally invasive option for tumor management.
Clinical Applications
Commonly used in the treatment of pancreatic solid masses, the device is applied in scenarios where endoscopic ultrasound guidance is feasible. It is particularly useful for patients with pancreatic ductal adenocarcinoma.
Evidence Summary
The literature includes 13 studies ranging from case reports to systematic reviews, primarily published between 2019 and 2022. These studies explore the feasibility and outcomes of EUS-guided RFA in pancreatic lesions.
Reported Outcomes
Published studies report the feasibility of EUS-guided longitudinal FNABs and gene expression changes associated with the tumor microenvironment. Early outcomes suggest potential benefits in the ablation of pancreatic lesions.
Safety Profile
Reported complications include challenges in interpreting results due to retrospective designs and small sample sizes. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by small sample sizes and retrospective study designs. Further research is needed to optimize power settings and ablation duration for effective treatment.
Frequently Asked Questions
What are the clinical indications for Habib EUS RFA?
The device is indicated for the ablation of pancreatic lesions, particularly in patients with pancreatic ductal adenocarcinoma.
What outcomes have been reported in clinical studies?
Studies report feasibility in collecting EUS-guided biopsies and potential benefits in tumor ablation, though results are preliminary.
What complications have been reported?
Reported complications include difficulties in result interpretation due to study design limitations. Specific adverse events were not detailed.
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.