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The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum. The BioProtect Balloon Implant System is composed of a balloon made of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

The BioProtect Balloon Implant™ System is composed of a single use, biodegradable, inflatable balloon implant, designed to act as a spacer between the prostate and the rectum. The BioProtect Balloon Implant System is supplied sterile. The balloon is implanted transperineally using transrectal ultrasound (TRUS) guidance and remains stable throughout the radiation treatment and gradually degrades over time. The BioProtect Balloon Implant System consists of single use components detailed below: 1. Balloon biodegradable, inflatable balloon acts as a spacer between the prostate and rectal wall. 2. Balloon Deployer delivery system, the balloon is mounted and folded on the deployer 3. Delivery Kit - an applicator system used to position and deploy the balloon in the intended location. It includes an 18-gauge echogenic needle, blunt-tipped tissue dilator, and balloon introducer sheath. The BioProtect Balloon Implant System is for prescription use only.