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solero microwave tissue ablation mta system and accessories
Angiodynamics
Summary: The Solero Microwave Tissue Ablation System is a device used for the ablation of soft tissue tumors. It is primarily utilized by interventional radiologists and oncologists in various clinical settings.
FDA Clearance Information
Pathway 510K
Number K213067 ↗
Decision Date December 3, 2021
Product Code NEY
Device Class Class 2
Evidence 1 studies
The Solero Microwave Tissue Ablation System by Angiodynamics was cleared via the FDA 510(k) pathway on December 3, 2021. It is classified as a Class 2 medical device under product code NEY.
What It Is
The Solero Microwave Tissue Ablation System is designed for the ablation of soft tissue tumors using microwave energy. It operates by delivering controlled microwave energy to the targeted tissue, causing coagulative necrosis and tissue destruction. This minimally invasive technique allows for precise targeting of tumors, making it a valuable tool in oncology.
Clinical Applications
This device is commonly used in the treatment of liver, lung, and kidney tumors. It is particularly beneficial in cases where surgical resection is not feasible. Interventional radiologists and oncologists use this system in hospital settings, often in conjunction with imaging guidance to ensure accurate placement of the ablation probe.
Indications for Use
The Solero Microwave Tissue Ablation System is indicated for the ablation of soft tissue tumors. It is suitable for patients with tumors that are difficult to access surgically or for those who are not surgical candidates.
Practical Considerations
The system is compatible with various imaging modalities for guidance, such as ultrasound and CT. It is important to consider the size and location of the tumor when planning the procedure, as well as the proximity to critical structures to avoid complications.
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 Solero Microwave Tissue Ablation System 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 oncologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors in patients who are not candidates for surgical resection.
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.