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Emprint Visualization Application
Summary: The Emprint Visualization Application is a medical device used for visualizing and planning tumor ablation procedures. It is primarily used by interventional radiologists and oncologists to assist in the treatment of tumors.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K192038 ↗
Decision Date ?
December 2, 2019
Product Code ?
LLZ
Device Class ?
Class 2
Evidence ?
11 studies
The Emprint Visualization Application was cleared through the FDA 510(k) pathway on December 2, 2019. Manufactured by Covidien, it is classified as a Class 2 medical device under product code LLZ.
What It Is
The Emprint Visualization Application is a software tool designed to assist clinicians in planning and executing tumor ablation procedures. It provides advanced imaging capabilities to visualize the target area and surrounding tissues, helping to ensure precise ablation. This application is particularly useful in enhancing the accuracy and safety of microwave ablation treatments.
FDA-Cleared Indications
- Planning and visualization of tumor ablation procedures.
- Use by clinicians to assist with image-based evaluation of the target area and surrounding tissues during ablation planning and treatment.
Clinical Applications
- Preprocedural planning for image-guided tumor ablation.
- Visualization of tumors and nearby anatomy before or during ablation.
- Assessment and visualization of the planned or created ablation zone.
- Use as part of image-guided microwave ablation procedures when compatible imaging and ablation equipment are available.
Practical Considerations
- The application is software rather than an implanted or disposable device; its performance depends on the connected imaging system, computer hardware, and facility configuration.
- Confirm compatibility, installation requirements, software version, calibration, and integration with the institution's imaging workflow before use.
- The application does not replace clinician judgment, image interpretation, biopsy when indicated, or established treatment planning for tumor ablation.
- MRI compatibility depends on the specific computer, displays, accessories, room setup, and connected imaging equipment; the software itself should not be described as MRI safe without reviewing the applicable labeling.
- Use requires trained personnel familiar with image-guided ablation, software operation, treatment planning, and the limitations of visualization tools.
Related Literature
The linked study investigated the volume reduction of uterine fibroids following embolization or microwave treatment. Although 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 available abstract and publication year, which restricts detailed analysis of the study outcomes.
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 Visualization Application used for?
It is used for planning and visualizing tumor ablation procedures, particularly microwave ablation.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in planning and visualizing tumor ablation procedures, especially for 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.