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emprint procedure planning application
Covidien
Summary: The Emprint procedure planning application by Covidien is a device used primarily for tumor ablation. It is FDA 510k cleared and linked to studies comparing its efficacy in treating adenomyosis and metastatic lung tumors.
FDA Clearance Information
Pathway 510K
Number K142048 ↗
Decision Date September 17, 2014
Product Code LLZ
Device Class Class 2
Evidence 11 studies
The Emprint procedure planning application received FDA clearance through the 510k pathway on September 17, 2014. It is manufactured by Covidien and classified as a Class 2 device under product code LLZ.
What It Is
The Emprint procedure planning application is a device designed to assist clinicians in planning ablation procedures for tumors. It utilizes advanced imaging and planning algorithms to optimize treatment delivery and improve clinical outcomes.
Clinical Applications
Common clinical scenarios for the Emprint application include planning ablation procedures for patients with adenomyosis and metastatic lung tumors. It is used to enhance precision in targeting and treating tumor sites.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov. These studies focus on the efficacy of the Emprint application in treating adenomyosis and metastatic lung tumors, though specific sample sizes and completion dates are not provided.
Reported Outcomes
Published studies report that the Emprint procedure planning application is being evaluated for its efficacy in treating adenomyosis and metastatic lung tumors. However, detailed outcomes from these studies are not available in the provided evidence.
Safety Profile
Reported complications include potential adverse events associated with ablation procedures, though specific safety data from the studies are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data from the studies. Further research is needed to establish comprehensive efficacy and safety profiles for the Emprint application.
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 are the clinical indications for Emprint procedure planning application?
The device is indicated for planning ablation procedures in patients with tumors, including adenomyosis and metastatic lung tumors.
What outcomes have been reported in clinical studies?
Specific findings from the provided evidence are not detailed, but studies are evaluating efficacy in adenomyosis and metastatic lung tumors.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications detailed in the provided studies.
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.