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TrueFit Bolus is indicated for and intended to be placed on the patient's skin as an accessory to attenuate and/or compensate external beam (photon or electron) radiation during prescribed radiation therapy for the treatment of cancer or other non-malignant tissue conditions for which radiation therapy is indicated.

The device is for a single patient's use only and can be reused throughout the entirety of the treatment course.

The device is designed by the radiation therapy professional using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use.

The device is restricted to sale by or on the order of a physician and is by prescription only.

TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit.

Patient imaging data from the treatment planning system (TPS) are used as inputs to generate digital design of the radiation therapy bolus (TrueFit) by 3D Bolus Software Application (K213438), previously developed by Adaptiiv. The resulting output Stereolithography (STL) file is compatible with the third-party 3D printers. A TrueFit Bolus can be 3D-printed using MJF with polyamide or polyurethane, or SLA with methacrylate photopolymer resin, based on the user's preference.

The bolus is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The bolus acts as a tissue-equivalent material placed on the patient skin to account for the buildup region of the treatment beam.

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