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Emprint Ablation Visualization Application
Summary: The Emprint Ablation Visualization Application by Covidien is a medical device used for visualizing and guiding tumor ablation procedures. It is primarily used by interventional radiologists and oncologists to treat tumors through microwave ablation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180192 ↗
Decision Date ?
March 21, 2018
Product Code ?
LLZ
Device Class ?
Class 2
Evidence ?
11 studies
The Emprint Ablation Visualization Application was cleared by the FDA through the 510(k) pathway on March 21, 2018. Manufactured by Covidien, it is classified as a Class 2 medical device under product code LLZ.
What It Is
The Emprint Ablation Visualization Application is a software tool designed to assist clinicians in the visualization and guidance of microwave ablation procedures. It integrates with imaging systems to provide real-time feedback and precise targeting of tumor tissues. This application enhances the accuracy of ablation treatments, particularly in complex anatomical regions, by offering detailed visualization capabilities.
FDA-Cleared Indications
- Visualization and guidance of tumor ablation procedures.
- Use in patients with tumors considered suitable for treatment with microwave ablation.
Clinical Applications
- Planning and guiding image-based microwave ablation of tumors.
- Visualizing the treatment area during percutaneous or intraoperative tumor ablation.
- Supporting assessment of ablation coverage in tumors selected for microwave ablation.
Practical Considerations
- The application must be compatible with the facility's imaging system and associated ablation equipment.
- Use requires training in the software interface, image registration, ablation planning and interpretation of treatment-zone displays.
- Tumor size, shape, location and proximity to sensitive structures affect whether microwave ablation is appropriate and how the procedure is planned.
- The software is an imaging and guidance aid; it does not replace clinical judgment, image quality assessment or standard safety checks.
- MRI compatibility depends on the connected imaging equipment and the specific installation. The application itself should not be assumed to be MRI safe without confirmation from the manufacturer and facility documentation.
Related Literature
The linked study investigated the volume reduction of uterine fibroids following embolization or microwave treatment. While specific details and findings are not available, the study likely aimed to compare the efficacy of these two treatment modalities. Limitations include the lack of an abstract and detailed results, which restricts the ability to draw definitive conclusions from the study.
Linked Studies (11)
PubMed • 2023
Emprint Microwave Thermoablation System: Bridging Thermal Ablation Efficacy between Human Patients and Porcine Models through Mathematical Correlation.
Bioengineering (Basel, Switzerland)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Comparative Study of Ablation Zone of EMPRINT HP Microwave Device with Contemporary 2.4 GHz Microwave Devices in an Ex Vivo Porcine Liver Model.
Diagnostics (Basel, Switzerland)
View Source →PubMed • 2021
New next-generation microwave thermosphere ablation for small hepatocellular carcinoma.
Clinical and molecular hepatology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2020
A review of conventional and newer generation microwave ablation systems for hepatocellular carcinoma.
Journal of medical ultrasonics (2001)
View Source →PubMed • 2019
New microwave ablation system for unresectable liver tumors that forms large, spherical ablation zones.
Journal of gastroenterology and hepatology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2018
A novel 3-dimensional electromagnetic guidance system increases intraoperative microwave antenna placement accuracy.
HPB : the official journal of the International Hepato Pancreato Biliary Association
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2017
Microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions : New advances in interventional oncology: state of the art.
Medical oncology (Northwood, London, England)
View Source →PubMed • 2016
A new system of microwave ablation at 2450 MHz: preliminary experience.
Updates in surgery
View Source →PubMed • 2015
The Emprint™ Ablation System with Thermosphere™ Technology: One of the Newer Next-Generation Microwave Ablation Technologies.
Seminars in interventional radiology
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
View Source →ClinicalTrials.gov
Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter
View Source →Frequently Asked Questions
What is Emprint Ablation Visualization Application used for?
It is used for visualizing and guiding tumor ablation procedures, particularly with microwave ablation.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in the visualization and guidance of tumor ablation procedures, assisting in the treatment of tumors suitable for microwave ablation.
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.