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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).

The RectalPro™15 Endorectal Balloon device is a single-use disposable, inflatable, non-powered positioning device intended for us in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose of the device is to stabilize the prostate during Computed Tomography (CT) exam, and X-Ray when these imaging techniques are used for Radiation Therapy (RT) planning.

The RectalPro™ 75 Endorectal Balloon (ERB) is single use, disposable, inflatable, non-powered rectal device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. The RectalPro75 is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The ERB is inserted into the rectum and inflated prior to the start of a CT scan or RT therapy procedure. The device stabilizes the prostate once the device is inflated. The ERB is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. The RectalPro ERB is designed with a slim curved, extended shaft and balloon. The device is provided non-sterile to the end user, is not intended to be sterilized by the end user. It is packaged in a kit configuration, consisting of three primary components: 1. ERB shaft This is the shaft with attached balloon and attached clear plastic tubing for filling the balloon with air / water. The end of the tubing has a female luer lock. There are white markings on the side of the ERB shaft as insertion depth markings. 2. Stopper This is the circular plastic piece with one flat side, and one side containing four prongs. There is a hole in the middle of the stopper for placement onto the ERB shaft. 3. Air / water valve This is the small plastic valve on the air tube connected to the ERB shaft. The clamp on the air / water tube stops the air / water flow by squeezing the tube closed. This component stops air / water from releasing out of the balloon after it has been filled. The kit also includes a standard 100 cc syringe with male luer lock connector, for connecting to the female luer connection of the ERB tubing, and is used to deliver the water or air to the ERB.

The Myriad Prostate Caddy™ Immobilization Rectal Balloon is a single-use disposable, inflatable, non-powered positioning device intended for use in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose of the device is to stabilize the prostate during Computed Tomography (CT) exam and Xray, when these imaging techniques are used for Radiation Therapy (RT) planning. The placement of the balloon requires a Physician or a Physician directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

The Myriad Prostate Caddy™ Immobilization Rectal Balloon is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The Prostate Immobilization Rectal Balloon is inserted into the rectum and inflated prior to the start of a CT scan or RT therapy procedure. The device stabilizes the prostate once the device is inflated. The Prostate Immobilizer Rectal Balloon is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. Myriad's device is designed for single use, is provided non-sterile to the end user, is not intended to be sterilized by the end user, and is packaged in a kit configuration. Each kit contains the following items: Rectal Balloon (PVC); Syringe (optional accessory to the device); Locking Stopper (accessory to the device) and the Instructions for Use. The balloon consists of a single lumen shaft with a blow molded balloon attached to the distal end of the shaft. The balloon is bonded to the shaft at the proximal end of the balloon. The shaft extends into the balloon but it is not attached at the end with a rounded atraumatic tip. Several eye holes are provided to inflate/deflation of the balloon. The main section of the device consists of a balloon and single lumen tubing which are made of PVC. The remainder of the device is made of other medical grade materials consisting of the following components shown below in Table 1. The device can be inflated with either air or water, and this process is carried out with the single use disposable syringe that is supplied (or offered as an option) with the device in the accessory kit. The locking stopper supplied with the Prostate Immobilizer Rectal Balloon controls the depth at which the balloon is inserted into the rectum. The device can therefore be locked into place once inserted into place.

The ERB is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.

The ERB is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and Xray, when these imaging techniques are used for Radiation Therapy (RT) planning. The ERB is inserted into the rectum and inflated prior to the start of a CT scan or RT therapy procedure. The device stabilizes the prostate once the device is inflated. The ERB is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. The ERB is designed for single use, is provided non-sterile to the end user, and is not intended to be sterilized by the end user. The ERB consists of a balloon and tubing can be inflated with either water or air. The device can be locked into place once inserted into the rectum with a locking stopper.

The RadiaDyne Prostate Immobilizer Rectal Balloon is a single-use disposable, inflatable, non-powered positioning device intended for use in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose of the device is to stabilize the prostate during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The placement of the balloon requires a Physician or a Physician directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

The RadiaDyne Prostate Immobilizer Rectal Balloon is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The Prostate Immobilizer Rectal Balloon is inserted into the rectum and inflated prior to the start of a CT scan or RT therapy procedure. The device stabilizes the prostate once the device is inflated. The Prostate Immobilizer Rectal Balloon is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. RadiaDyne's device is designed for single use, is provided non-sterile to the end user, is not intended to be sterilized by the end user, and is packaged in a kit configuration. Each kit contains the following items: Rectal Balloon (polyurethane); Syringe (accessory to the device); Lubricant (accessory to the device); Locking Stopper (accessory to the device); and Instructions Manual. The main section of the device consists of a balloon and tubing which are made of polyurethane. The remainder of the device is made from other medical grade materials. The device can be inflated with either air or water, and this process is carried out with the single use disposable syringe that is supplied with the device in the accessory kit. The locking stopper supplied with the Prostate Immobilizer Rectal Balloon controls the depth at which the balloon is inserted into the rectum. The device can therefore be locked into place once inserted into place. RadiaDyne's Prostate Immobilizer Rectal Balloon is offered with a gas release valve (Models GRB) and without a gas release valve (Models: RB). Prior to insertion of the balloon, rectal gas can be removed from the rectum by methods not involving the balloon, such as inserting a pediatric catheter. The gas release model incorporates an open conduit through the balloon stem so that the rectal gas can be released once the balloon is inserted. After inflation, the gas release conduit continues to provide an escape path for any additional gas arriving at the superior end of the balloon, thus preventing gas accumulation during the procedure. The gas release valve is always open and does not require any action to function. If the model without the gas release valve is used, some transient gas may accumulate during the procedure, as is customary when no balloon is inserted. Aside from this feature, the GRB and RB models are identical in materials, construction and function.