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habib eus rfa
Emcision
Summary: The Habib EUS RFA is a radiofrequency ablation device used for treating pancreatic lesions. Key evidence highlights its feasibility in EUS-guided procedures and potential for gene expression analysis in tumor microenvironments.
FDA Clearance Information
Pathway
510K
Number
K161305 ↗
Decision Date
July 7, 2016
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Habib EUS RFA was cleared by the FDA via the 510(k) pathway on July 7, 2016. It is manufactured by Emcision and classified as a Class 2 device.
What It Is
The Habib EUS RFA is a device designed for endoscopic ultrasound-guided radiofrequency ablation of pancreatic lesions. It utilizes radiofrequency energy to ablate targeted tissue, primarily used in the management of pancreatic tumors.
Clinical Applications
Commonly used in the treatment of pancreatic solid masses, the Habib EUS RFA is applied in scenarios requiring minimally invasive ablation, such as inoperable pancreatic tumors or cystic lesions.
Evidence Summary
The available literature includes 13 studies, comprising case series, systematic reviews, and preclinical comparisons, spanning from 2019 to 2022. These studies explore the device's feasibility, efficacy, and safety in various clinical settings.
Reported Outcomes
Published studies report the feasibility of collecting EUS-guided biopsies and assessing gene expression changes in the tumor microenvironment. The device shows promise in the ablation of pancreatic lesions, although results are often limited by small sample sizes and retrospective designs.
Safety Profile
Reported complications include the need for further optimization of power settings and ablation duration, as preclinical studies indicate variability in the macroscopic zone of hepatic injury. No significant adverse events have been consistently reported in the available literature.
Evidence Limitations
The evidence is limited by small sample sizes, retrospective study designs, and a lack of standardized protocols for power settings and ablation duration. Further research is needed to optimize clinical outcomes and validate findings in larger, prospective trials.
Frequently Asked Questions
What are the clinical indications for Habib EUS RFA?
The Habib EUS RFA is indicated for the ablation of pancreatic solid masses and cystic lesions, particularly in cases where minimally invasive procedures are preferred.
What outcomes have been reported in clinical studies?
Studies report feasibility in EUS-guided procedures and potential for assessing gene expression changes in tumor microenvironments, with promising results in pancreatic lesion ablation.
What complications have been reported?
Reported complications include variability in the ablation zone and the need for optimization of power settings, with no significant adverse events consistently 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.