TrueFit Bolus; TrueFlex Bolus
Adaptiiv Medical Technologies, Inc.TrueFit Bolus and TrueFlex Bolus are 3D printed patient-specific bolus accessories used in external beam radiation therapy to ensure accurate radiation dose delivery near the skin surface. Designed using patient imaging data, these devices improve treatment precision and patient comfort by compensating for tissue irregularities during cancer treatment.
Intended Use
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 or on the order of a physician and is by prescription only.
Technology
TrueFit/TrueFlex Bolus devices are 3D printed radiation therapy accessories designed using patient imaging data from treatment planning systems. TrueFit Bolus uses multi-jet fusion 3D printing with polyamide or polyurethane materials, while TrueFlex Bolus is manufactured using silicone by filling a 3D printed mold. These materials provide customized fit and radiological properties to accurately deliver radiation doses.
Performance
Verification and Validation testing using worst-case geometrical samples and real patient devices showed acceptable spatial fidelity and radiological properties, ensuring precise fit and safe, effective radiation delivery. Performance testing confirmed substantial equivalence to the legally marketed predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
26 days - 2
FDA Approval
10/23/2024
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