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lv liberty vision model 1 90 yttrium brachytherapy source
Lv Liberty Vision
Summary: The Lv Liberty Vision Model 1 90 Yttrium 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 for treating certain types of cancer.
FDA Clearance Information
Pathway
510K
Number
K163572 ↗
Decision Date
March 15, 2017
Product Code
KXK
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on March 15, 2017, by Lv Liberty Vision. It is classified as a Class 2 medical device under product code KXK.
What It Is
The Lv Liberty Vision Model 1 90 Yttrium Brachytherapy Source is a specialized device used in brachytherapy, a form of internal radiation treatment. It delivers yttrium-90, a radioactive isotope, directly to the tumor site, allowing for high-dose radiation therapy while minimizing exposure to surrounding healthy tissues. This device is particularly useful in treating liver cancers and other malignancies where precision is critical.
Clinical Applications
This device is commonly used in interventional radiology and oncology settings for the treatment of liver tumors, such as hepatocellular carcinoma and metastatic liver disease. It is employed in procedures known as y90-radioembolization or selective internal radiation therapy (SIRT), where it provides targeted radiation to cancerous tissues. Patients who are not candidates for surgical resection or who have limited treatment options may benefit from this therapy.
Indications for Use
The FDA indications for this device involve its use in delivering targeted radiation therapy to tumors, particularly in the liver. It is indicated for patients with primary or metastatic liver cancer, where traditional surgical or systemic therapies are not feasible.
Practical Considerations
The device requires careful handling and precise placement to ensure effective treatment. It is compatible with catheter-based delivery systems used in interventional radiology. Clinicians should be trained in radiation safety and the specific techniques for y90-radioembolization to optimize outcomes.
Related Literature
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Frequently Asked Questions
What is Lv Liberty Vision Model 1 90 Yttrium Brachytherapy Source used for?
It is used for delivering targeted radiation therapy to treat liver tumors, such as hepatocellular carcinoma and metastatic liver disease.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in the treatment of liver cancers.
What are the FDA-cleared indications?
The device is indicated for use in delivering targeted radiation therapy to liver tumors, particularly 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.