đź“Š Evidence-Based Reference
emprint ablation system with thermosphere technology overall system name emprint ablation generator cagen1 emprint ablation generator hp cagenhp emprint ablation pump capump1 covidien ablation footswitch rfasw emprint reinforced percutaneous antenna 15cm ca15l2 emprint reinforced percutaneous antenna 20cm ca20l2 emprint reinforced percutaneous antenna 30cm ca30l2 covidien remote temperature probe rtp20 covidien remote temperature probe bulk rtp20b
Medtronic
Summary: The Emprint Ablation System with Thermosphere Technology is a microwave ablation device primarily used for tumor ablation. Key evidence highlights its efficacy in creating predictable ablation zones.
FDA Clearance Information
Pathway 510K
Number K233838 ↗
Decision Date March 28, 2024
Product Code NEY
Device Class Class 2
Evidence 11 studies
The Emprint Ablation System was cleared by the FDA via the 510(k) pathway on March 28, 2024. Manufactured by Medtronic, it is classified as a Class 2 medical device.
What It Is
The Emprint Ablation System is a microwave ablation device designed to treat tumors by creating predictable spherical ablation zones. It is intended for use in percutaneous and intraoperative tumor ablation procedures.
Clinical Applications
Commonly used in the treatment of lung and liver tumors, the Emprint Ablation System is applied in scenarios where surgical resection is not feasible. It is particularly useful in non-operable patients requiring minimally invasive treatment.
Evidence Summary
The available literature includes 8 studies, ranging from 2015 to 2022, comprising prospective trials and reviews. These studies evaluate the system's efficacy and safety in tumor ablation.
Reported Outcomes
Published studies report that the Emprint Ablation System effectively creates large, predictable ablation zones, particularly in lung and liver tumors. The system is noted for its high thermal efficiency and ability to maintain consistent ablation zone shapes across different tissue environments.
Safety Profile
Reported complications include concerns about the reproducibility of ablation zone sizes in human tissues, as highlighted in some studies. Overall, the system is considered safe, with no significant adverse events reported in the reviewed literature.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to confirm long-term outcomes and safety in diverse patient populations.
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 Ablation System?
The Emprint Ablation System is indicated for the ablation of tumors in the lung and liver, especially in patients who are not candidates for surgical resection.
What outcomes have been reported in clinical studies?
Clinical studies report effective ablation of tumors with predictable zone sizes and shapes, particularly in lung and liver applications.
What complications have been reported?
Safety data from evidence indicate concerns about the reproducibility of ablation zones, but no significant adverse events have been reported.
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.