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Emprint Ablation System with Thermosphere Technology Emprint SX Ablation Platform with Thermosphere Technology
Summary: The Emprint Ablation System with Thermosphere Technology is a microwave ablation device primarily used for treating tumors. Key evidence highlights its efficacy in creating predictable ablation zones.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K193232 ↗
Decision Date ?
February 13, 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 February 13, 2020. 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 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
- Coagulation and ablation of soft tissue during open and percutaneous procedures.
- Treatment of tumors when tissue coagulation or ablation is clinically indicated.
- Use with compatible Emprint microwave ablation accessories and the Emprint SX Ablation Platform.
Clinical Applications
- Percutaneous microwave ablation of selected tumors under image guidance.
- Intraoperative microwave ablation of selected tumors during open surgery.
- Ablation of selected primary or metastatic tumors in soft tissue, including tumors of the liver or lung, when consistent with the device labeling and clinical judgment.
- Creation of a controlled zone of thermal coagulation around the microwave applicator.
Reported off-label uses
- Microwave ablation of tumors in organs or locations not specifically included in the applicable product labeling.
- Ablation of benign tissue conditions or non-tumor lesions when supported by clinical practice or published literature.
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 8 studies, comprising prospective trials and reviews, conducted between 2015 and 2022. These studies evaluate the device'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 liver and lung tumors. The system's ability to maintain consistent ablation zone size regardless of tissue environment is noted as a significant advantage. Clinical trials have demonstrated its efficacy in treating non-operable lung cancer and small hepatocellular carcinoma.
Safety Profile
Reported complications include concerns about the reproducibility of ablation zone size in human tissue, as some studies were based on preclinical models. However, no specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials directly comparing the Emprint System to other ablation technologies. Further research is needed to confirm long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The system requires the compatible Emprint SX Ablation Platform and microwave ablation applicators; applicator size and active-tip length should be selected for the target lesion and access route.
- Placement is generally performed with imaging guidance, such as computed tomography, ultrasound, or another appropriate modality, or directly during surgery.
- The device delivers thermal energy and requires attention to nearby organs, vessels, airways, bile ducts, nerves, and other heat-sensitive structures.
- MRI safety depends on the specific applicator, cable, generator, and procedure configuration. Do not bring the system or applicators into an MRI environment unless the applicable labeling specifically permits it.
- Patient selection, contraindications, grounding or dispersive-pad requirements if applicable, sterile handling, and treatment settings should follow the current manufacturer instructions for use.
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, including non-operable lung tumors and small hepatocellular carcinoma.
What outcomes have been reported in clinical studies?
Studies have reported effective tumor ablation with predictable zone sizes, particularly in liver and lung applications.
What complications have been reported?
Reported complications include concerns about the predictability of ablation zone size in human tissue, though specific adverse events were not 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.