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TrueFit/TrueFlex Bolus is indicated for and intended to be placed on the patient's skin as an accessory to attenuate and/or compensate the external beam (photon or electron) radiation during the treatment of various types of cancer. 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 on the order of a physician and is by prescription only.

TrueFit/TrueFlex 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 (TrueFlex) by 3D Bolus Software Application (K213438), previously developed by Adaptiv. The resulting output Stereolithography (STL) file is compatible with the third-party 3D printers. A TrueFit Bolus is 3D printed by MJF technology using polyamide or polyurethane material. A Final TrueFlex Bolus device is manufactured by filling a mould with silicone. 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.

Nova Surface Applicator is indicated for and intended to be placed on the patient's skin to navigate an HDR radiation source during the treatment of various types of cancer using brachytherapy. The device is for a single patient's use only and can be reused throughout the entirety of the treatment plan. The device is designed by radiation therapy professionals 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.

Adaptiv's Nova Surface applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of brachytherapy by providing a patient-specific fit and catheter trajectory design. Patient imaging data from the treatment planning system (TPS) are used as inputs to generate digital design of the surface brachytherapy applicator by 3D Brachy Software Application (K213438), previously developed by Adaptiv. The resulting output Stereolithography (STL) file is compatible with the third-party 3D printers. Nova Surface applicator navigates a radiation source toward tumors located closely to or on the surface of the body (e.g. skin cancers). It fits the patient's anatomy by means of a patient-specific contact surface ensuring that optimal dose is delivered to a target surface of the body. It accommodates catheter tunnels which guide the HDR brachytherapy radiation source according to the patient-specific design input chosen by users. A surface brachytherapy applicator device is 3D printed by Stereolithography (SLA) technology using methacrylic resin.