Solero Mta Cart Solero Mta System Solero Microwave Tissue Ablation Applicator 14cm Solero Microwave Tissue Ablation Applicator 19cm Solero Microwave Tissue Ablation Applicator 29cm
Product: Solero — all models and sizes
FDA Clearance Information
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
FDA-Cleared Indications
- Ablation of soft-tissue tumors.
- Use when the tumor is accessible through a percutaneous, laparoscopic, or open surgical approach.
Clinical Applications
- Image-guided percutaneous ablation of accessible soft-tissue tumors.
- Laparoscopic ablation of accessible soft-tissue tumors.
- Open surgical ablation of accessible soft-tissue tumors.
- Treatment planning using applicator lengths selected for the tumor location and access route.
Reported off-label uses
- Microwave ablation of selected liver, lung, and kidney tumors outside the specific limitations of the device labeling may be performed in clinical practice, but the appropriateness and regulatory status depend on the individual case and applicable labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Applicators are available in 14 cm, 19 cm, and 29 cm lengths; the appropriate length depends on the access route, patient anatomy, and target depth.
- Placement is typically monitored with imaging such as CT or ultrasound, depending on the target and procedure.
- The operator must assess the distance from the tumor to critical structures and account for microwave heat spread and the planned ablation zone.
- The system is intended for use by trained clinicians in an appropriate hospital or procedural setting.
- MRI compatibility should be confirmed in the current manufacturer labeling before bringing any system component into the MRI environment; do not assume the applicator or generator is MRI safe.
Linked Studies (1)
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.