Search Results

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.

3D Bolus and 3D Brachy applications are indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy, and surface brachytherapy. Users may choose to send the Stereolithography (STL) files to Adaptiiv Medical Technologies Inc. to 3D print the external beam radiation therapy accessories to the specification of the prescribing radiation therapy professional or 3D print either external beam or surface brachytherapy accessories in-house. If 3D printing is performed by Adaptiiv Medical Technologies Inc., 3D printed accessories will be sent to the requesting care center for the final quality control and acceptance by the trained radiation therapy personnel. The use of 3D Bolus and 3D Brachy applications as well as the 3D printed radiation therapy accessories is by prescription only.

Adaptiv Medical Technologies Inc. solution is software as a medical device that consist of two (2) separate desktop applications: - 3D Bolus Software Application, which includes the Simple Bolus and Modulated Electron Bolus modules; a. - 3D Brachy Software Application, which includes the Surface Brachytherapy module. b. The 3D Bolus and 3D Brachy software applications enable trained radiation therapy personnel to use DICOM and DICOM RT files from the radiation therapy treatment planning system (TPS) as inputs to produce Stereolithography (STL) files are compatible with the third-party 3D printing of the customized, patient-matched accessories for external beam radiation therapy, and or surface brachytherapy applicators in-house or through Adaptiv's OnDemand function. Accessories generated by the Adaptiv's software must be verified by the trained radiation therapy professionals on their TPS for correctness prior to print initiation or accessory order through Adaptiiv OnDemand. Adaptiv's 3D printed patient-matched radiation therapy accessory that expands the application of external-beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. If 3D printing is to be performed by Adaptiv Medical Technologies Inc., desired external beam radiation therapy accessories will be 3D printed using the HP Jet Fusion 5200 Series 3D Printing Solution. Adaptiiv Medical Technologies Inc. has validated the Ultrasint® Thermoplastic polyurethane (TPU01) powder for use in 3D printing of radiation therapy accessories.