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emprint visualization application
Covidien
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 510K
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.
Clinical Applications
This device is commonly used in interventional radiology and oncology settings for the treatment of various tumors, including liver and kidney tumors. It aids in pre-procedural planning and intra-procedural guidance, allowing for more accurate targeting and monitoring of ablation zones. The application is beneficial in both hospital and outpatient settings, particularly for patients undergoing minimally invasive tumor ablation procedures.
Indications for Use
The Emprint Visualization Application is indicated for use in planning and visualizing tumor ablation procedures. It is suitable for patients with tumors that are candidates for microwave ablation, providing clinicians with enhanced imaging to improve treatment outcomes.
Practical Considerations
The application is compatible with standard imaging modalities and integrates with existing hospital systems. Clinicians should ensure proper calibration and compatibility with their imaging equipment. Familiarity with the software interface is recommended for optimal use during procedures.
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.