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TheraSphere 360 Y-90 Management Platform
Summary: The Therasphere 360 Y-90 Management Platform is a medical device used for Y-90 radioembolization, primarily in the treatment of liver cancer. It is utilized by interventional radiologists and oncologists to deliver targeted radiation therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K252547 ↗
Decision Date ?
October 28, 2025
Product Code ?
LLZ
Device Class ?
Class 2
Evidence ?
14 studies
The Therasphere 360 Y-90 Management Platform was cleared via the FDA 510k pathway on October 28, 2025. Manufactured by Boston Scientific, it is classified as a Class 2 device under product code LLZ.
What It Is
The Therasphere 360 Y-90 Management Platform is a sophisticated device designed for the administration of Yttrium-90 (Y-90) microspheres. These microspheres are used in radioembolization procedures to deliver targeted radiation therapy directly to liver tumors. The platform facilitates precise dosimetry and delivery, enhancing the safety and efficacy of the treatment.
FDA-Cleared Indications
- Used to support the administration of Y-90 microspheres for radioembolization of liver tumors.
- Intended for treatment planning, dosimetry and delivery management during Y-90 radioembolization.
- Used in catheter-based treatment of primary and metastatic liver tumors as specified in the device labeling.
Clinical Applications
- Planning and performing Y-90 radioembolization for selected liver tumors.
- Supporting dosimetry calculations for targeted radiation delivered through the hepatic arterial circulation.
- Managing delivery of Y-90 microspheres during selective internal radiation therapy.
- Use in multidisciplinary care involving interventional radiology, oncology, nuclear medicine and medical physics.
Practical Considerations
- Treatment requires hepatic arterial catheterization, angiographic mapping and careful assessment of liver function, tumor distribution and arterial anatomy.
- The platform is used with Y-90 microspheres and compatible catheter-based delivery equipment; clinicians should follow the current manufacturer instructions for use.
- Planning commonly includes evaluation for vessels that could carry microspheres to the stomach, duodenum or other organs, with embolization or other corrective measures when appropriate.
- Patients require radiation-safety procedures, activity calculation, handling controls and post-treatment monitoring by trained personnel.
- MRI safety and compatibility depend on the specific platform components and accessories; consult the current labeling before MRI examination.
Procedures that use this device
Linked Studies (14)
PubMed • 2025
TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial.
JMIR research protocols
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical and dosimetric considerations for yttrium-90 glass microspheres radioembolization of intrahepatic cholangiocarcinoma, metastatic colorectal carcinoma, and metastatic neuroendocrine carcinoma: recommendations from an international multidisciplinary working group.
European journal of nuclear medicine and molecular imaging
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Clinical, dosimetric, and reporting considerations for Y-90 glass microspheres in hepatocellular carcinoma: updated 2022 recommendations from an international multidisciplinary working group.
European journal of nuclear medicine and molecular imaging
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Cost-effectiveness analysis of personalised versus standard dosimetry for selective internal radiation therapy with TheraSphere in patients with hepatocellular carcinoma.
Frontiers in oncology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2021
The cost-effectiveness of TheraSphere in patients with hepatocellular carcinoma who are eligible for transarterial embolization.
European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2018
Comparison of the Adverse Event Profile of TheraSphere® with SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma: A Systematic Review.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2016
Outcomes of Therasphere Radioembolization for Colorectal Metastases.
Clinical colorectal cancer
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2011
Radioembolization for hepatocellular carcinoma using TheraSphere®.
Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2009
Yttrium-90 radioembolization using TheraSphere in the management of primary and secondary liver tumors.
The quarterly journal of nuclear medicine and molecular imaging : official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR), [and] Section of the Society of...
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2007
Yttrium-90 microspheres (TheraSphere and SIR-Spheres) for the treatment of unresectable hepatocellular carcinoma.
Issues in emerging health technologies
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors
View Source →ClinicalTrials.gov
TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma
View Source →ClinicalTrials.gov
Internal Radiation Therapy for Hepatocellular Carcinomas With Therasphere: Optimized Dosimetry Versus Standard Dosimetry
View Source →Frequently Asked Questions
What is Therasphere 360 Y-90 Management Platform used for?
It is used for the targeted delivery of Y-90 radioembolization therapy to treat liver cancer.
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 treatment of primary and metastatic liver tumors requiring localized radiation therapy.
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.