Procedure
The biodegradable BioProtect Balloon spacer is deployed in a quick and minimally invasive procedure using a unique, blunted tip insertion device, enabling delivery of the balloon into its optimal position.
The procedure is performed under local or general anesthesia and guided by trans-rectal ultrasound. Once the balloon is in situ, it is inflated with sterile saline to reach the desired final space and sealed in place. The balloon implant remains inflated during the treatment and is absorbed over time.
Clinical Data
Use of a Biodegradable, Contrast-Filled Rectal Spacer Balloon in Intensity-Modulated Radiotherapy for Intermediate-Risk Prostate Cancer Patients: Dosimetric Gains in the BioPro-RCMI-1505 Study
Read More
Is prostate cancer radiotherapy using implantable rectum spacers safe and effective in inflammatory bowel disease patients?
Ben G.L. Vanneste et al.
Read More50-Gy Stereotactic Body Radiation Therapy to the Dominant Intraprostatic Nodule: Results From a Phase 1a/b Trial
Fernanda G. Herrera et al.
Read MoreA biodegradable rectal balloon implant to protect the rectum during prostate cancer radiotherapy for a patient with active Crohn’s disease
Ben G.L. Vanneste et al.
Read MoreApplication of an interstitial and biodegradable balloon system for prostate-rectum separation during prostate cancer radiotherapy: a prospective multi-center study
Eliahu Gez et al.
Read MoreInterstitial biodegradable balloon for reduced rectal dose during prostate radiotherapy: Results of a virtual planning investigation based on the pre- and post-implant imaging data of an international multicenter study
Transperineal Implementation of Biocompatible Balloon in Patients Treated With Radiotherapy for Prostate Carcinoma: Feasibility and Quality Assurance Study in Terms of Anatomical Stabilization Using Image Registration Techniques
Vassilis K et al.
Read MoreFAQ
The balloon is made of medical-grade PLA-ε-Caprolactone, a biodegradable polymer commonly used in medical devices. It is filled with sterile saline during the procedure, presenting no risk of embolisms due to the penetration of foreign materials into the bloodstream.
The balloon is 44mm long and 35mm wide and may provide a space of up to 1.8cm.
The balloon remains inflated during radiation treatment and is absorbed over time. It usually completely biodegrades within six months post-implantation. Therefore, it does not require additional procedures for removal.
You can use general, regional-epidural, or local anesthesia, with or without sedation anesthesia.
The balloon can be easily repositioned before final sealing. Fully deflate the balloon before repositioning, then safely relocate the balloon to your ideal desired position.
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A BioProtect Representative or a fully trained user must train a new user. The learning curve for a physician experienced with performing trans-perineal procedures is usually 3-4 procedures.
Hydrodissection is not necessary. However, hydrodisection may be used if you encounter tissue resistance.
The balloon cannot be purchased in the US at this time as it is pending FDA approval. Once approval is received, the website will be updated to contain purchase information.
