Search Results

The VHA Radiotherapy Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VHA Radiotherapy Boluses are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. The VHA Radiotherapy Bolus product must be verified and approved by the radiation therapy professional prior to use on a patient. The VHA Radiotherapy Bolus is intended for patients of all ages receiving radiotherapy treatment. VHA Radiotherapy Bolus was evaluated using 6 MV photons and 9MeV electrons but has not been assessed for use with protons or at orthovoltage X-rays.

Boluses are used in external beam radiation therapy (EBRT) to change the depth of the radiation dose delivered, thereby overcoming the skin-sparing effect. Using clinical treatment planning software (TPS) and clinical expertise, a radiotherapy clinician designs the bolus to conform with the patient anatomy. The bolus is produced using additive manufacturing in a soft elastomeric material to conform to the patient's skin. The bolus is placed on the patient and verified for fit and acceptance to the clinical treatment plan prior to initiating treatment.

The OMF ASP System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the OMF ASP System, and the result is an output data file that may then be provided as digital models or used as input to an additive manufacturing portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The OMF ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

The Oromaxillofacial Advanced Surgical Planning (OMF ASP) System utilizes Commercial Off-the-Shelf (COTS) software to manipulate 3D medical images (CT-based systems) with surgeon input, and to produce digital and physical patient specific outputs including surgical plans, anatomic models, templates, and surgical guides for planning and performing maxillofacial surgeries. The system utilizes medical imaging, such as CT-based imaging data of the patient's anatomy to create surgical plans with input from the physician to inform surgical decisions and guide the surgical procedure. The system produces a variety of patient specific to the maxillofacial region including anatomic models (physical and digital), physical surgical templates and/or guides, and patient specific case reports. The system utilizes additive manufacturing to create patient specific guides, and anatomical models.