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sir-spheres microspheres
Sirtex Medical
Summary: SIR-Spheres microspheres are used for radioembolization in liver cancer treatment. Key evidence supports their use in unresectable metastatic colorectal cancer and hepatocellular carcinoma.
FDA Clearance Information
Pathway PMA
Number P990065 ↗
Decision Date February 27, 2015
Product Code NAW
Device Class Class 3
Evidence 11 studies
The SIR-Spheres microspheres were cleared by the FDA through the PMA pathway on February 27, 2015. Manufactured by Sirtex Medical, they are classified as Class 3 devices.
What It Is
SIR-Spheres microspheres are yttrium-90 resin microspheres used for selective internal radiation therapy (SIRT). They deliver targeted radiation to liver tumors, minimizing exposure to healthy tissue.
Clinical Applications
Commonly used in the treatment of unresectable liver tumors, including hepatocellular carcinoma and metastatic colorectal cancer. They are often considered when other treatments are not viable.
Evidence Summary
The literature includes 14 studies, with types ranging from cost analyses to procedural guidelines, published between 2021 and 2024. These studies explore clinical efficacy, cost-effectiveness, and procedural aspects.
Reported Outcomes
Published studies report that SIR-Spheres microspheres are effective in treating unresectable liver tumors, providing a viable option when surgery is not possible. They have shown cost-effectiveness compared to other treatments in certain scenarios.
Safety Profile
Reported complications include typical risks associated with radioembolization, such as post-embolization syndrome and potential radiation-induced liver disease. However, studies generally indicate a favorable safety profile.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials directly comparing SIR-Spheres with other treatment modalities. Further research is needed to fully understand long-term outcomes and safety.
Linked Studies (11)
PubMed • 2024
90Y SIR-Spheres Activity Measurement with New SIROS D-Vial Delivery Kit.
Journal of nuclear medicine technology
View Source → PubMed • 2021
A cost-utility analysis of SIR-Spheres Y-90 resin microspheres versus best supportive care in the treatment of unresectable metastatic colorectal cancer refractory to chemotherapy in the UK.
Journal of medical economics
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2021
A cost analysis of SIR-Spheres yttrium-90 resin microspheres versus tyrosine kinase inhibitors in the treatment of unresectable hepatocellular carcinoma in France, Italy, Spain and the UK.
Journal of medical economics
View Source → PubMed • 2021
Retrospective SPECT/CT dosimetry following transarterial radioembolization.
Journal of applied clinical medical physics
Retrospective View Source → PubMed • 2020
SIR-Spheres yttrium-90 radioembolization for the treatment of unresectable liver cancers.
Hepatic oncology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2018
The SIRveNIB and SARAH trials and the role of SIR-Spheres® Y-90 resin microspheres in the management of hepatocellular carcinoma.
Future oncology (London, England)
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2018
Recommendations for SIR-Spheres Y-90 resin microspheres in chemotherapy-refractory/intolerant colorectal liver metastases.
Future oncology (London, England)
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 • 2015
Primary standardization of SIR-Spheres based on the dissolution of the (90)Y-labeled resin microspheres.
Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine
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 →Frequently Asked Questions
What are the clinical indications for SIR-Spheres microspheres?
Indicated for treating unresectable liver tumors, including hepatocellular carcinoma and metastatic colorectal cancer.
What outcomes have been reported in clinical studies?
Studies report effectiveness in tumor control and cost-effectiveness compared to other treatments.
What complications have been reported?
Reported complications include post-embolization syndrome and potential radiation-induced liver disease.
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.