đź“‹ FDA Reference
Emprint SX Ablation Platform and Accessories
Coviden
Summary: The Emprint SX Ablation Platform is a microwave ablation device used for tumor treatment. It is primarily used by interventional radiologists and surgeons to accurately target and ablate tumors in various clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K171358 ↗
Decision Date ?
September 1, 2017
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
11 studies
The Emprint SX Ablation Platform by Coviden was cleared through the FDA 510k pathway on September 1, 2017. It is classified as a Class 2 device under product code NEY.
What It Is
The Emprint SX Ablation Platform is a medical device designed for microwave ablation of tumors. It utilizes a 3D-electromagnetic guidance system to enhance the precision of antenna placement during procedures. This platform allows for real-time tracking and guidance, improving the accuracy of tumor targeting and ablation, which is crucial for effective treatment outcomes.
FDA-Cleared Indications
- Ablation of soft-tissue tumors.
- Use with compatible microwave ablation antennas and accessories during percutaneous, laparoscopic, or open procedures, as specified in the applicable device labeling.
Clinical Applications
- Microwave ablation of accessible soft-tissue tumors.
- Percutaneous tumor ablation performed with image guidance.
- Laparoscopic or open surgical tumor ablation when used with compatible equipment and accessories.
- Treatment planning and antenna-placement guidance using the platform's electromagnetic tracking capability.
Reported off-label uses
- Ablation of selected benign tumors or non-tumor tissue conditions has been reported for microwave ablation systems, but this is not necessarily included in the Emprint SX labeling and should not be assumed to be cleared for this device.
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.
Practical Considerations
- The system is used with compatible microwave ablation antennas and accessories; antenna dimensions, active-tip length, and available configurations depend on the specific accessory model and labeling.
- Antenna placement requires image guidance and careful planning to avoid critical structures and to cover the intended treatment zone.
- The electromagnetic guidance function requires appropriate system setup and may be affected by nearby conductive objects or equipment; users should follow the manufacturer's instructions.
- This is a thermal ablation system, not an MRI scanner or MRI-conditional implant. MRI compatibility depends on the individual antenna, accessory, and procedural environment; the applicable labeling should be checked before MRI use.
- Contraindications, warnings, tissue limitations, and compatibility requirements vary by antenna and accessory. The current FDA-cleared instructions for use should be reviewed before each procedure.
Related Literature
The linked study investigated the impact of the Emprint SX Ablation Platform's 3D-electromagnetic guidance system on the accuracy of microwave antenna placement. The study found that the system improved intraoperative placement accuracy, potentially leading to more effective tumor ablation. However, the study was conducted in a laparoscopic training model, and further research in clinical settings is needed to confirm these findings.
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 is the Emprint SX Ablation Platform used for?
It is used for the microwave ablation of soft tissue tumors, enhancing precision in tumor targeting and treatment.
What specialties typically use this device?
Interventional radiologists and surgical oncologists commonly use this device for tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors in patients where microwave ablation is appropriate.
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.