bioProtect

Essential information

for prostate cancer patients considering or undergoing radiation therapy

What are radiotherapy spacers?
Spacers make radiotherapy safer

Research shows that radiation therapy is better for avoiding urinary incontinence and impotence. The only disadvantage of radiation is related to the exposure of normal tissue to harmful radiation. In prostate cancer the organ at risk is the rectum, which is very close to the prostate. The rectum is often exposed to unwanted radiation, leading to complications of bowel function and injury to the rectum.

The ProSpace balloon spacer creates a temporary space between the rectum and the prostate, pushing the rectum away from harmful radiation.

Protecting you

External beam radiation therapy (EBRT) is highly effective in killing prostate cancer cells, but a potential side effect is rectal toxicity due to the proximity of the prostate to the rectum. Rectal toxicity is associated with the following symptoms, which can be short- or long-term:

  • Diarrhea
  • Mucus discharge
  • Rectal bleeding
  • Rectal leaking
  • Rectal pain
  • Fecal incontinence
  • Fecal urgency

Your doctor will make every effort to reduce the risk of rectal toxicity when choosing the radiation dosage and duration, as well as the frequency of the sessions. Another proven method to avoid rectal toxicity is to introduce a spacer that physically distances the rectum from the prostate.

Ask your doctor about the BioProtect Spacer

a safe, easy-to-deploy, biodegradable balloon that prevents rectal toxicity.

The Radiation vs. Toxicity Dilemma

External beam radiation therapy (EBRT) is the gold standard treatment for localized prostate cancer patients. Although studies show that higher radiation doses achieve better long-term tumor control, the higher the dose, the more likely that the adjacent rectal tissue will suffer damage. This dilemma also exists with the more recent advances in radiation therapy such as Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT). Although these methods are more accurate and more effective, parts of the rectal wall are still frequently exposed to high radiation doses.

The BioProtect Balloon Implant

BioProtect’s biodegradable Balloon Implant shifts the rectum away from the prostate, allowing physicians to radiate prostate tumors at the more effective escalated daily doses without damaging healthy rectal tissue. This treatment method might allow your doctor to shorten the overall treatment time.

Simple Deployment

The balloon implant is deployed into the prostate-rectum interspace in a quick and minimally invasive transperineal technique using a unique insertion device. The procedure is performed under local or general anesthesia, guided by transrectal ultrasound. The procedure might be performed during the fiducial markers implant stage. Once in place, the balloon is inflated with sterile saline to reach its final configuration. The balloon implant remains inflated during the entire treatment period and completely biodegrades in the body after six months.

DEPLOYMENT
PROCEDURE

The Benefits of BioProtect’s Balloon Implant

Safe distance for dose escalation:
Shifts the rectum up to 1.8 cm from the prostate, creating ideal conditions for dose escalation with a dramatic reduction of the risk of radiation-related complications.
Visible under any imaging modality:
The balloon boundaries are highly visible under ultrasound, CT, MRI or any other imaging modality used by your doctor.
Reproducible separation
Your doctor has complete control over the size of the inflated implant, which is maintained throughout the treatment period.
Safe and simple procedure
Implantation under local or general anesthesia using blunt dissection near rectal wall to ensure safety
Biodegradable
within six months of implantation, no need for surgical removal.