đź“‹ FDA Reference
solero microwave tissue ablation mta system and accessories
Angiodynamics
Summary: The Solero Microwave Tissue Ablation System is a medical device used for the ablation of soft tissue tumors. It is primarily used by interventional radiologists and oncologists in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K223581 ↗
Decision Date
March 27, 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 27, 2023. It is a Class 2 device under product code NEY.
What It Is
The Solero Microwave Tissue Ablation System is designed to deliver microwave energy to ablate soft tissue tumors. It operates by generating heat through microwave energy, causing coagulative necrosis of the targeted tissue. This system is often used in minimally invasive procedures, providing a precise and controlled method to treat tumors.
Clinical Applications
This device is commonly used in interventional radiology and oncology for the treatment of liver, kidney, and lung tumors. It is suitable for use in both inpatient and outpatient settings, offering a less invasive alternative to surgical resection. The system is particularly beneficial for patients who are not surgical candidates due to the location of the tumor or underlying health conditions.
Indications for Use
The FDA indications for the Solero System include ablation of soft tissue tumors. Clinically, this means it can be used to treat patients with tumors in organs such as the liver, kidneys, and lungs, where traditional surgery may not be feasible.
Practical Considerations
The Solero System typically includes various probe sizes to accommodate different tumor sizes and locations. It is compatible with imaging guidance systems for precise placement. Clinicians should be trained in microwave ablation techniques to ensure optimal outcomes.
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 the liver, kidneys, and lungs.
What specialties typically use this device?
Interventional radiologists and oncologists primarily use this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors.
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.