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Emprint Ablation System with Thermosphere Technology
Product: Emprint HP — all models and sizes
Summary: The Emprint Ablation System with Thermosphere Technology is a microwave ablation device used primarily for tumor treatment. Key evidence suggests it creates predictable ablation zones, offering an alternative for non-operable tumors.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K200796 ↗
Decision Date ?
August 26, 2020
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 August 26, 2020. Manufactured by Covidien, it is classified as a Class 2 device.
What It Is
The Emprint Ablation System is a microwave ablation device designed to treat tumors by creating predictable spherical ablation zones. It utilizes Thermosphere Technology to maintain consistent energy delivery across varying tissue environments.
FDA-Cleared Indications
- Microwave ablation of tumors using dedicated microwave ablation antennas and a generator.
- Treatment of malignant and benign tumors when microwave ablation is clinically appropriate.
- Use in percutaneous and intraoperative procedures under imaging guidance.
Clinical Applications
- Image-guided percutaneous microwave ablation of selected liver tumors.
- Image-guided percutaneous microwave ablation of selected lung tumors.
- Intraoperative microwave ablation of tumors when surgical exposure is available.
- Local tumor ablation for patients who are not candidates for surgical resection or who require a tissue-sparing treatment.
Reported off-label uses
- Microwave ablation of selected renal tumors.
- Microwave ablation of selected adrenal tumors.
- Microwave ablation of selected bone or soft-tissue tumors.
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 literature includes 8 studies, comprising prospective trials and reviews, published between 2015 and 2022. These studies evaluate the safety and efficacy of the Emprint Ablation System in clinical settings.
Reported Outcomes
Published studies report that the Emprint Ablation System effectively creates large, predictable ablation zones, which are beneficial in treating small hepatocellular carcinoma and lung tumors. The system's ability to maintain consistent ablation zone size across different tissue types is highlighted as a significant advantage.
Safety Profile
Reported complications include concerns about the reproducibility of ablation zone size in human tissues, as some studies are based on preclinical models. However, no specific adverse events are detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the reliance on preclinical models for ablation zone prediction, raising concerns about applicability in human tissues. Further research is needed to confirm long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The system uses microwave ablation antennas in different lengths and active-tip configurations; the appropriate antenna depends on tumor location, size, access route and the planned ablation zone.
- Treatment planning requires imaging assessment of tumor size, nearby organs, blood vessels and heat-sensitive structures. Multiple overlapping ablations may be needed for larger or irregular tumors.
- The device is generally used with ultrasound, CT or other appropriate imaging guidance and may be performed with local anesthesia and moderate sedation or with general anesthesia, depending on the procedure.
- MRI compatibility depends on the specific generator, antenna, cables and accessories. Do not bring the system or an antenna into the MRI environment unless the specific component is labeled for that setting.
- Potential contraindications and precautions include unsafe needle access, uncorrectable bleeding risk, active infection, inability to tolerate anesthesia or positioning, and tumor involvement of structures that cannot be safely protected from heat.
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 device is indicated for the treatment of liver and lung tumors, particularly in patients who are not surgical candidates.
What outcomes have been reported in clinical studies?
Studies report effective creation of predictable ablation zones, particularly beneficial for small hepatocellular carcinoma and lung tumors.
What complications have been reported?
Reported complications include concerns about the reproducibility of ablation zone size in human tissues, with no specific adverse events detailed.
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.