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Our Solution

Predictable, Reproducible, Adjustable, and Safe Space

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The Problem

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 movements within or between sessions leave parts of the rectal wall exposed to high radiation doses, which may result in rectal toxicity or proctitis.

The Solution

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.

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48mm length
18mm height
Up to 17ml inflation volume
6 months to substantial absorption
35mm width

BioProtect Balloon Implant™ System

The BioProtect Balloon spacer provides up to 18mm separation between the rectal wall and the treated area before commencing radiation therapy.

Using a minimally invasive, the balloon is introduced quickly under ultrasound guidance, using a transperineally 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.

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Provides optimal organ separation through optimal positioning
Saline filled biodegradable balloon, minimally invasive implanted under TRUS guidance
Provides safe distance between prostate and rectum
6 months to substantial absorption
Visible under any imaging modality (CT, Ultrasound, MRI)

The Procedure

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Step 1: Prepare for
Balloon Insertion

  • An Ultrasound guidance probe inserted into the rectum
  • Superficial needle insertion for blunt dissection guidance
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Step 2: Perform
Blunt Dissection

  • 6mm incision made at the insertion point
  • Blunt dilator inserted at the peri-rectal space
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Step 3: Insert
Balloon Implant

  • Folded balloon inserted via the sheath
  • Saline-filled syringe attached to the BioProtect Balloon system
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Step 4: Balloon
Deployment

  • 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
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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