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Lv Liberty Vision Model 1 90yttrium Brachytherapy Source
Lv Liberty Vision
Summary: The Lv Liberty Vision Model 1 90Yttrium Brachytherapy Source is a medical device used for targeted radiation therapy, specifically in y90-radioembolization procedures. It is primarily utilized by interventional radiologists and oncologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K193602 ↗
Decision Date ?
May 29, 2020
Product Code ?
KXK
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on May 29, 2020. It is manufactured by Lv Liberty Vision and classified as a Class 2 medical device.
What It Is
The Lv Liberty Vision Model 1 90Yttrium Brachytherapy Source is a device that delivers localized radiation therapy using yttrium-90, a radioactive isotope. It is designed for brachytherapy, a form of internal radiation treatment where the source is placed close to or inside the tumor. This approach allows for high doses of radiation to target cancer cells while minimizing exposure to surrounding healthy tissues.
FDA-Cleared Indications
- Use in Y-90 radioembolization procedures to deliver localized radiation therapy.
- Use as a brachytherapy source for the treatment of appropriate malignant tumors according to the device labeling and treatment protocol.
Clinical Applications
- Y-90 radioembolization of selected liver tumors.
- Selective internal radiation therapy performed through catheter-directed delivery to the hepatic arterial circulation.
- Targeted radiation treatment when localized internal radiation is clinically appropriate.
Practical Considerations
- The source contains radioactive Y-90 and must be ordered, transported, stored, handled and disposed of under applicable radiation-safety regulations.
- Treatment requires specialized planning, catheter-based delivery and confirmation of the intended vascular distribution, typically with interventional radiology and oncology involvement.
- The device is used with compatible brachytherapy or radioembolization delivery equipment; compatibility must be confirmed before treatment.
- Patient selection requires assessment of liver function, tumor distribution, arterial anatomy and the risk of non-target embolization.
- MRI safety information should be confirmed in the current device labeling and facility policy; radioactive source safety does not by itself establish MRI compatibility.
Related Literature
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Procedures that use this device
Frequently Asked Questions
What is Lv Liberty Vision Model 1 90Yttrium Brachytherapy Source used for?
It is used for targeted radiation therapy in y90-radioembolization procedures, primarily for treating liver cancer.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in y90-radioembolization, a procedure for delivering targeted radiation therapy to treat certain cancers, especially liver cancer.
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.