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solero mta cart 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 used by interventional radiologists and oncologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K182250 ↗
Decision Date February 28, 2019
Product Code NEY
Device Class Class 2
Evidence 1 studies
The Solero MTA System, manufactured by Angiodynamics, was cleared via the FDA 510k pathway on February 28, 2019. It is a Class 2 medical device.
What It Is
The Solero MTA System is a microwave tissue ablation device designed to treat tumors by delivering precise microwave energy to the target tissue. It includes multiple applicator lengths (14cm, 19cm, 29cm) to accommodate different anatomical locations and tumor sizes. The system operates by generating heat through microwave energy, causing coagulative necrosis of the tumor tissue.
Clinical Applications
The Solero MTA System is commonly used in interventional radiology and oncology for the ablation of liver, lung, and kidney tumors. It is particularly useful in patients who are not surgical candidates or where traditional surgery poses significant risks. The device is typically used in hospital settings, often in conjunction with imaging guidance such as ultrasound or CT to ensure precise targeting.
Indications for Use
The FDA-cleared indications for the Solero MTA System include the ablation of soft tissue tumors. It is intended for patients with tumors that are accessible via percutaneous, laparoscopic, or open surgical approaches.
Practical Considerations
The Solero MTA System offers flexibility with its range of applicator lengths, making it adaptable to various tumor locations and sizes. Clinicians should consider the proximity of critical structures and the thermal profile when planning ablation procedures. Compatibility with imaging modalities is essential for accurate placement and monitoring.
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 microwave ablation of soft tissue tumors, such as those in the liver, lung, and kidney.
What specialties typically use this device?
Interventional radiologists and oncologists typically use the Solero MTA System for tumor ablation procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include the ablation of soft tissue tumors, suitable for patients with tumors accessible via percutaneous, laparoscopic, or open surgical approaches.
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.