TheraSphere 360 indications, safety, and warnings

The TheraSphere 360 Platform includes Treatment Planning and Activity Calculation functionalities as optional interactive tools intended for calculating the activity of TheraSphere Microspheres required at treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass. The Treatment Planning and Activity Calculation functionalities include features to aid in TheraSphere Microspheres dose vial selection. Additionally, the TheraSphere 360 Platform includes optional post-treatment analysis functionalities to be used following treatment with TheraSphere Microspheres. For post-TheraSphere Microspheres treatment, the TheraSphere 360 Platform should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for pre-treatment planning when there is a need for retreatment using TheraSphere Microspheres.

• A thorough understanding of the technical principles, clinical applications, and risks associated with the TheraSphere Microspheres procedure is necessary before using this product.
• Observe all indications, contraindications, warnings, and precautions noted in the TheraSphere Y-90 Glass Microsphere System IFU and the TheraSphere 360 Platform IFU before attempting to use the TheraSphere 360 Platform.
• Inappropriate use of the TheraSphere 360 Platform may lead to patient harm. Refer to the TheraSphere 360 Platform IFU and TheraSphere Y-90 Glass Microsphere System IFU for proper use, indications, contraindications, warnings, and precautions before attempting to use the TheraSphere 360 Platform.
• Ensure that the specified treatment values are in accordance with the guidance provided in the TheraSphere Microspheres label.
• Confirm accuracy of all data entry prior to finalizing treatment plans. Incorrect data input may lead to unintentionally inaccurate outputs which could lead to patient harm.
• Final treatment plans must be reviewed and approved by the Authorized User for the planned treatment. The application indicates whether the activity of your vial at time of treatment is within ± 10% of what you specified in the Dosimetry workflow step. Verify that the activity is valid for the planned treatment.

Refer to the TheraSphere Y-90 Glass Microsphere System IFU for additional Precautions. The TheraSphere 360 Platform displays content that may include patient data that are protected health information. Patient data should only be accessed by authorized health care providers and Boston Scientific personnel.

• Do not share your password to prevent unauthorized access.
• Ensure your internet browser is up to date and your connection is secure and stable prior to using the TheraSphere 360 Platform.
• Be sure to log out of the TheraSphere 360 Platform before closing your browser.
• If you are experiencing Login or Browser issues, close out of all tabs, restart the browser, and log back into the TheraSphere 360 Platform.
• The TheraSphere 360 Platform site administrators should monitor and maintain Authorized User access.

Refer to the TheraSphere Y-90 Glass Microsphere System IFU for Adverse Events. Any serious incident that occurs in relation to this device should be reported to Boston Scientific and the relevant local regulatory authority.