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sir-spheres microspheres activity calculator smac
Sirtex Medical Us Holdings
Summary: The Sir-Spheres Microspheres Activity Calculator (SMAC) is a medical device used to calculate the appropriate dose of microspheres for radioembolization procedures. It is typically used by interventional radiologists in the treatment of liver tumors.
FDA Clearance Information
Pathway
510K
Number
K202392 ↗
Decision Date
October 23, 2020
Product Code
KPS
Device Class
Class 2
Evidence
11 studies
The Sir-Spheres Microspheres Activity Calculator SMAC was cleared through the FDA 510(k) pathway on October 23, 2020. Manufactured by Sirtex Medical US Holdings, it is classified as a Class 2 device under product code KPS.
What It Is
The Sir-Spheres Microspheres Activity Calculator (SMAC) is a specialized tool designed to assist clinicians in determining the correct activity of yttrium-90 microspheres for radioembolization therapy. This device plays a crucial role in ensuring accurate dosing, which is essential for the effective treatment of hepatic malignancies. By providing precise calculations, it helps optimize therapeutic outcomes while minimizing potential side effects.
Clinical Applications
The SMAC is predominantly used in interventional radiology, particularly in procedures involving the treatment of primary and metastatic liver tumors. It is utilized in hospital settings where radioembolization is performed, often in collaboration with oncologists and hepatologists. The device aids in the planning and execution of selective internal radiation therapy (SIRT), ensuring that patients receive a tailored dose of radiation based on their specific clinical parameters.
Indications for Use
The FDA indications for the SMAC involve its use in calculating the activity of microspheres for patients undergoing radioembolization. It is intended for individuals with liver tumors, including those with hepatocellular carcinoma or metastatic liver disease, who are candidates for selective internal radiation therapy.
Practical Considerations
Clinicians should ensure compatibility with the specific yttrium-90 microspheres used in their practice. Familiarity with the device's interface and calculation parameters is essential for accurate dosing. It is important to consider patient-specific factors such as liver function and tumor burden when using the calculator.
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 is the Sir-Spheres Microspheres Activity Calculator SMAC used for?
It is used to calculate the appropriate dose of yttrium-90 microspheres for radioembolization in liver cancer treatment.
What specialties typically use this device?
Interventional radiologists primarily use this device, often in collaboration with oncologists and hepatologists.
What are the FDA-cleared indications?
The device is indicated for calculating microsphere activity in patients undergoing radioembolization for liver tumors.
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.