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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
510K
Number
K171358 ↗
Decision Date
September 1, 2017
Product Code
NEY
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.
Clinical Applications
This device is commonly used in the treatment of liver, lung, and kidney tumors. It is particularly valuable in interventional radiology and surgical oncology settings where precise ablation is critical. The platform is suitable for use in both inpatient and outpatient settings, catering to adult patients who require minimally invasive tumor ablation procedures.
Indications for Use
The Emprint SX Ablation Platform is indicated for the ablation of soft tissue tumors. It is used in patients with tumors that are accessible for microwave ablation, offering a minimally invasive option for tumor management.
Practical Considerations
The device is compatible with standard laparoscopic equipment and requires careful consideration of antenna placement for optimal results. Clinicians should be familiar with the electromagnetic guidance system to maximize the device's potential in improving procedural accuracy.
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.