Rectal toxicity stems from the rectum’s proximity to the prostate. It is a highly prevalent complication during prostate cancer radiation therapy. Despite technological advancements and careful and precise treatment planning, prostate movement within or between sessions leave parts of the rectal wall exposed to high radiation doses, which may result in rectal toxicity or proctitis.
Hypofractionation and dose escalation are leading treatments for prostate radiation. There is a growing need for a solution to protect the rectum from the high-dose radiation field, significantly reduce rectal toxicity, and pave the way to safer and more cost-effective radiation therapy techniques.
BioProtect Balloon Implant™ System
BioProtect Balloon spacer is the answer to this need. With its unique design and shape, the balloon provides up to 18mm of separation between the rectal wall and the treated area before commencing radiation therapy.
During the minimally invasive procedure, the balloon is introduced under ultrasound guidance, using a transperineal technique, with local or general anesthesia. Once the balloon is placed between the prostate and the rectum, it is filled with sterile saline and positioned to gain its final configuration.
The balloon provides reproducible separation between the prostate and rectum, and is visible under all imaging modalities, including CT, MRI, and ultrasound. The balloon maintains its size and shape in the body during the radiation course period and naturally biodegrades over time.
Step 1: Prepare for
- An Ultrasound guidance probe inserted into the rectum
- Superficial needle insertion for blunt dissection guidance
Step 2: Perform
- 6mm incision made at the insertion point
- Blunt dilator inserted at the peri-rectal space
Step 3: Insert
- Folded balloon inserted via the sheath
- Saline-filled syringe attached to the BioProtect Balloon system
Step 4: Deploy
- The sheath is retracted, leaving the folded balloon in position
- Saline fills the BioProtect Balloon, and the balloon is sealed – creating separation necessary to protect healthy tissue from high dose radiation
Step 5: Treat Prostate
while Protecting Healthy Tissues
- A course of radiation therapy is performed with minimized risk to OARs
- No need for spacer removal procedure – 6 months to substantial absorption