bioProtect

Essential information

for prostate cancer patients considering or undergoing radiation therapy

What are radiotherapy spacers?
Spacers make radiotherapy safer

In prostate radiation therapy, a highly prevalent complication is rectal toxicity that stems from the rectum’s close proximity to the prostate. Despite technological advancements and meticulous treatment planning, prostate movements within or in between sessions leave parts of the rectal wall exposed to high radiation doses, which results in rectal toxicity or proctitis.

There is a growing need for a solution that protects the rectum from the high-dose radiation field. With such a device, the chance for rectal toxicity will dramatically be reduced. This will pave the way to more cost-effective radiation therapy techniques such as hypofractionation.

The BioProtect Balloon Implant™ System spacer creates a temporary space between the treated area and adjacent healthy tissue, pushing normal tissue 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 GI toxicity due to the proximity of the prostate to the GI tract. GI toxicity is associated with the following symptoms, which can be short- or long-term:

  • Diarrhea
  • Bleeding
  • Pain
  • Incontinence

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

Ask your doctor about the BioProtect Spacer

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

Radiation Side Effects

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 GI 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 GI tract are still frequently exposed to high radiation doses.

The BioProtect Balloon Implant

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

Simple Deployment

The balloon implant is deployed in a quick and minimally invasive transperineal technique using a unique insertion device. The procedure is performed under local or general anesthesia, guided by 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 over time.

DEPLOYMENT
PROCEDURE

The Benefits of BioProtect’s Balloon Implant

Safe distance for dose escalation:
Shifts healthy tissue up to 2cm from the prostate, creating ideal conditions for dose escalation with a 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 and shape of the inflated implant, which is maintained throughout the treatment period.
Safe and simple procedure
Implantation under local or general anesthesia using blunt dissection to ensure safety
Biodegradable
over time, no need for surgical removal.