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
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 ?
510(k)
Number ?
K233838 ↗
Decision Date ?
March 28, 2024
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 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.
FDA-Cleared Indications
- Percutaneous and intraoperative coagulation and ablation of soft-tissue tumors.
- Use with the Emprint ablation generator, pump, footswitch, antennas, and temperature-probe accessories as part of the ablation system.
- The system is intended to create controlled microwave ablation zones in targeted soft tissue.
Clinical Applications
- Percutaneous microwave ablation of selected liver tumors.
- Percutaneous microwave ablation of selected lung tumors.
- Intraoperative ablation of soft-tissue tumors when used during surgery.
- Treatment of selected tumors when surgical removal is not appropriate or feasible, based on the treating clinician's assessment.
Reported off-label uses
- Microwave ablation of selected kidney tumors has been reported for this device category in clinical practice.
- Microwave ablation of selected adrenal, bone, or other soft-tissue tumors has been described in clinical 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, 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.
Practical Considerations
- The system includes the CAGEN1 standard generator, CAGENHP high-power generator, CAPUMP1 pump, RFASW footswitch, reinforced percutaneous antennas in 15 cm, 20 cm, and 30 cm lengths, and remote temperature probes.
- Antenna selection depends on tumor location, access route, target size, and the amount of normal tissue that can safely be included in the ablation zone.
- The procedure is performed with imaging guidance, commonly computed tomography or ultrasound, and may use local anesthesia with moderate sedation or general anesthesia depending on the approach.
- The system should be used only with compatible components and according to the current manufacturer instructions for use. Microwave ablation requires attention to heat injury, grounding is not generally required, and nearby organs or structures may require protective techniques.
- MRI compatibility is component- and configuration-specific; do not bring the generator, pump, footswitch, antennas, or temperature probes into the MRI environment unless the current labeling specifically identifies them as MR Safe or MR Conditional.
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.