therasphere 360 y-90 management platform
Boston Scientific
FDA Clearance Information
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
Clinical Applications
Indications for Use
Practical Considerations
Linked Studies (14)
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 →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 →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 →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 →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 →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 →Outcomes of Therasphere Radioembolization for Colorectal Metastases.
Clinical colorectal cancer
RCT|prospective|retrospective|case Series|other View Source →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 →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 →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 →Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors
View Source →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.