đź“‹ FDA Reference
Emprint SX Ablation Platform with Thermosphere Technology
Summary: The Emprint SX Ablation Platform with Thermosphere Technology is a medical device used for tumor ablation. It is primarily utilized by interventional radiologists and surgeons for precise tumor targeting and ablation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K203303 ↗
Decision Date ?
December 17, 2020
Product Code ?
NEY System, Ablation, Microwave And Accessories
Device Class ?
Class 2
Evidence ?
11 studies
The Emprint SX Ablation Platform was cleared by the FDA through the 510k pathway on December 17, 2020. Manufactured by Covidien, it is classified as a Class 2 medical device.
What It Is
The Emprint SX Ablation Platform is an advanced tumor ablation device that uses microwave energy to destroy cancerous tissue. It features Thermosphere Technology, which helps maintain consistent energy delivery and ablation zone size, ensuring effective treatment. The device includes a 3D electromagnetic guidance system for precise antenna placement, enhancing the accuracy of ablation procedures.
FDA-Cleared Indications
- Ablation of soft-tissue tumors.
- Use with compatible microwave ablation antennas and accessories for targeted tissue ablation.
Clinical Applications
- Image-guided microwave ablation of soft-tissue tumors.
- Percutaneous tumor ablation when access through the skin is appropriate.
- Laparoscopic tumor ablation.
- Open surgical tumor ablation.
Practical Considerations
- The system uses microwave energy and compatible antennas; antenna selection depends on the target's size, location, and required ablation zone.
- Procedures may use ultrasound, CT, or other appropriate imaging guidance, along with the platform's three-dimensional electromagnetic guidance capabilities.
- The system is intended for trained clinicians familiar with microwave ablation, antenna placement, thermal injury prevention, and management of complications.
- MRI compatibility depends on the specific generator, antenna, guidance components, and accessories. Do not bring the system or its components into an MRI environment unless their labeling specifically permits it.
- Patient selection must account for tumor location, nearby organs and vessels, bleeding risk, infection risk, and whether surgery, radiation, systemic medication, or surveillance is more appropriate.
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 the precision of antenna placement in a laparoscopic training model, potentially leading to more effective tumor ablation. However, the study was limited to a training environment 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 ablation of soft tissue tumors, particularly in the liver, lung, and kidney.
What specialties typically use this device?
Interventional radiologists and surgical oncologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, providing a minimally invasive treatment option for certain cancer patients.
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.