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The DxTx Medical Pro-Tx Endorectal Balloon is a disposable, single use non-powered inflatable positioning device intended to be used for temporary positioning of the rectal wall and adjacent structures in the male human anatomies and to assist in positioning the prostate in a more predictable and reproducible location. The purpose of the DxTx Medical Pro-Tx Endorectal Balloon is to stabilize the rectal wall and surrounding anatomy during all phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. Only trained healthcare professionals are intended to operate this device.

The DxTx Medical Pro-Tx Endorectal Balloon is a disposable, single use device for immobilization and localization of the rectal wall and surrounding anatomy on a daily basis for radiation therapy treatment. The Pro-Tx Endorectal Balloon includes the shaft and inflatable balloon with a gas venting feature. The Pro-Tx Endorectal Balloon is capable of being filled with air or fluid. The intended contact duration of the device is less than 60 minutes. No components of this device contain medicinal substances, tissues or blood products. The device component materials are PVC, Polycarbonate, Polyethylene, Polypropylene, Copolyester, Liquid Silicone Rubber (balloon), and brass (the radiopaque marker).