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emprint ablation visualization application
Covidien
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 510K
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.
Clinical Applications
This device is commonly used in interventional radiology and oncology settings for the treatment of various tumors, including liver, kidney, and lung tumors. It is particularly useful in minimally invasive procedures where precise targeting and monitoring of ablation zones are critical. The application is suitable for use in both hospital and outpatient settings, aiding in the treatment of patients who are candidates for microwave ablation therapy.
Indications for Use
The FDA-cleared indications for this device include its use in the visualization and guidance of tumor ablation procedures. It is intended for patients with tumors that are amenable to microwave ablation, providing clinicians with enhanced imaging support during treatment.
Practical Considerations
Clinicians should ensure compatibility with existing imaging systems and be familiar with the software interface for optimal use. The application may require specific training to maximize its utility in guiding ablation procedures. It is important to consider the size and location of the tumor when planning treatment with this device.
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.