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emprint sx ablation platform with thermosphere technology
Covidien
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 510K
Number K203303 ↗
Decision Date December 17, 2020
Product Code NEY
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.
Clinical Applications
This device is commonly used in interventional radiology and surgical oncology for the treatment of liver, lung, and kidney tumors. It is suitable for use in both open and laparoscopic procedures, providing versatility across different surgical settings. The platform is particularly beneficial for patients who are not candidates for traditional surgical resection due to tumor location or patient comorbidities.
Indications for Use
The Emprint SX Ablation Platform is indicated for the ablation of soft tissue tumors. It is particularly useful for patients with liver, lung, or kidney tumors, offering a minimally invasive treatment option that can be performed in a variety of clinical settings.
Practical Considerations
The device is compatible with various antenna sizes, allowing customization based on tumor size and location. Clinicians should be familiar with the 3D guidance system to maximize placement accuracy. Proper training in microwave ablation techniques is recommended to ensure optimal outcomes.
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.