đź“Š Evidence-Based Reference
Emprint Ablation System
Product: Emprint — all models and sizes
Summary: The Emprint Ablation System is a microwave ablation device used primarily for tumor ablation. Key evidence highlights its efficacy in creating predictable ablation zones, particularly in liver and lung tumors.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K163105 ↗
Decision Date ?
December 6, 2016
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
11 studies
The Emprint Ablation System was cleared by the FDA via the 510(k) pathway on December 6, 2016. It is manufactured by Covidien and classified as a Class 2 device.
What It Is
The Emprint Ablation System is a microwave ablation device designed for the treatment of tumors. It uses electromagnetic waves to generate heat, creating predictable ablation zones for effective tumor destruction.
FDA-Cleared Indications
- Microwave ablation of soft tissue using electromagnetic energy to generate localized heat.
- Treatment of tumors in patients selected for thermal ablation according to the device labeling and treatment system configuration.
Clinical Applications
- Percutaneous microwave ablation of selected liver tumors under image guidance.
- Percutaneous microwave ablation of selected lung tumors under image guidance.
- Surgical or laparoscopic microwave ablation of selected soft-tissue tumors when used according to the system labeling.
- Creation of a planned thermal ablation zone around a targeted tumor while limiting treatment to the intended tissue.
Reported off-label uses
- Microwave ablation of selected kidney tumors.
- Microwave ablation of selected adrenal tumors.
- Microwave ablation of selected bone or soft-tissue metastases.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 9 studies, comprising prospective trials, reviews, and clinical trials, conducted between 2015 and 2022. 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, spherical ablation zones, particularly in liver and lung tumors. The system's predictability and efficiency in ablation are highlighted as significant advantages.
Safety Profile
Reported complications include potential variability in ablation zone size and shape due to tissue environment differences. However, newer technology in the Emprint System aims to mitigate these issues.
Evidence Limitations
Evidence gaps include a need for more randomized controlled trials to further validate efficacy and safety. Some studies lack detailed outcomes and safety data, indicating areas for further research.
Practical Considerations
- The system uses microwave antennas and compatible generators; antenna length, active tip configuration and treatment settings must match the specific system instructions for use.
- Treatment is typically performed with CT, ultrasound or another appropriate imaging modality, with attention to nearby vessels, bile ducts, airways, bowel, nerves and other heat-sensitive structures.
- Patient selection depends on tumor size, number, location, access route, organ function and whether surgery, radiation, systemic therapy or another ablation method is more appropriate.
- The device is not an MRI scanner accessory by default. MRI compatibility depends on the specific antenna, cable, generator and procedure configuration; the applicable labeling must be checked before MRI use.
- Potential complications include bleeding, infection, injury to adjacent organs, pneumothorax for lung procedures, bile-duct injury for liver procedures and incomplete or recurrent tumor treatment.
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, particularly in the liver and lungs, in patients who are not candidates for surgical resection.
What outcomes have been reported in clinical studies?
Studies report effective creation of large, predictable ablation zones, particularly in liver and lung tumors, with high thermal efficiency.
What complications have been reported?
Reported complications include variability in ablation zone size and shape, although newer technology aims to address these issues.
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.