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solero mta system solero microwave tissue ablation applicator 14cm solero microwave tissue ablation applicator 19cm solero microwave tissue ablation applicator 29cm
Angiodynamics
Summary: The Solero MTA System is a microwave tissue ablation device used for tumor ablation. It is primarily utilized by interventional radiologists and oncologists.
FDA Clearance Information
Pathway 510K
Number K162449 ↗
Decision Date May 5, 2017
Product Code NEY
Device Class Class 2
Evidence 1 studies
The Solero MTA System was cleared through the FDA 510k pathway on May 5, 2017. Manufactured by Angiodynamics, it is a Class 2 device under product code NEY.
What It Is
The Solero MTA System is a microwave tissue ablation device designed to treat tumors by delivering microwave energy to heat and destroy cancerous tissue. It consists of applicators available in 14cm, 19cm, and 29cm sizes, allowing for flexibility in reaching different tumor locations. The system operates by generating controlled microwave energy, which causes coagulative necrosis in targeted tissues.
Clinical Applications
This device is commonly used in interventional radiology and oncology settings for the treatment of liver, lung, and kidney tumors. It is particularly useful for patients who are not surgical candidates or for tumors that are difficult to access surgically. The Solero MTA System is often employed in minimally invasive procedures, providing a treatment option with reduced recovery time compared to traditional surgery.
Indications for Use
The FDA indications for the Solero MTA System include the ablation of soft tissue tumors. It is intended for use in patients with tumors that are accessible via percutaneous or open surgical approaches.
Practical Considerations
The Solero MTA System offers applicators in various lengths to accommodate different tumor locations and sizes. Clinicians should consider the size and location of the tumor when selecting the appropriate applicator. Compatibility with imaging guidance systems is essential for precise placement and monitoring during the procedure.
Linked Studies (1)
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 →Frequently Asked Questions
What is the Solero MTA System used for?
The Solero MTA System 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 oncologists typically use the Solero MTA System.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors that can be accessed percutaneously or surgically.
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.