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solero microwave tissue ablation mta system and accessories
Angiodynamics
Summary: The Solero Microwave Tissue Ablation System is used for the ablation of soft tissue tumors. It is primarily utilized by interventional radiologists and oncologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K221883 ↗
Decision Date March 7, 2023
Product Code NEY
Device Class Class 2
Evidence 1 studies
The Solero Microwave Tissue Ablation System by Angiodynamics was cleared via the FDA 510k pathway on March 7, 2023. It is a Class 2 medical device.
What It Is
The Solero Microwave Tissue Ablation System is a medical device designed for the ablation of soft tissue tumors using microwave energy. It works by generating heat through microwave energy, which causes coagulative necrosis of the targeted tissue. This system includes a generator and applicators that deliver precise energy to the tumor site, making it a minimally invasive option for tumor treatment.
Clinical Applications
This device is commonly used in the treatment of liver, lung, and kidney tumors. It is typically employed in interventional radiology suites or operating rooms. The Solero system is particularly useful for patients who are not surgical candidates due to the location of the tumor or other health considerations. It is often used in conjunction with imaging techniques such as CT or ultrasound to guide the procedure.
Indications for Use
The FDA indications for the Solero system include the ablation of soft tissue tumors. This means it is used to treat patients with tumors in organs like the liver, lungs, or kidneys, where surgical removal is not feasible.
Practical Considerations
The Solero system offers various applicator sizes to accommodate different tumor sizes and locations. It is compatible with standard imaging techniques for guidance. Clinicians should be familiar with the microwave ablation technique and consider patient-specific factors such as tumor size and location when planning treatment.
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 Microwave Tissue Ablation System used for?
It is used for the ablation of soft tissue tumors, particularly in organs like the liver, lungs, and kidneys.
What specialties typically use this device?
Interventional radiologists and oncologists primarily use this device.
What are the FDA-cleared indications?
The device is cleared for the ablation of soft tissue tumors, which includes treating tumors in organs such as the liver, lungs, and kidneys.
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.