Search Results

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.