Procedure
The biodegradable BioProtect Balloon spacer is deployed in a quick and minimally invasive procedure using a unique, blunted tip insertion device, enabling safe delivery of the balloon into its optimal position and ensuring that no tissue is injured during implantation.
The procedure is performed under local or general anesthesia and is 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
Multicenter, dual fractionation scheme, single core lab comparison of rectal volume dose reduction following injection of two biodegradable perirectal spacers
Micheal Kos et al.
Read MoreToxicity, quality of life, and PSA control after 50 Gy stereotactic body radiation therapy to the dominant intraprostatic nodule with the use of a rectal spacer: results of a phase I/II study.
Minna Cloitre et al.
Read MoreUse 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 Poly (L-lactide-co-ε-caprolactone), a biodegradable polymer commonly used in medical devices. It is filled with sterile saline during the procedure, presenting no risk of foreign materials into the bloodstream.
The balloon is 48mm 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. Therefore, it does not require additional procedures for removal. It usually takes 6 months to substantially absorb.
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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Hydrodissection is not mandatory. However, if tissue resistance is noticed, hydrodissection is optional using a slim tip syringe.
Please contact BioProtect Customer Service at customer-support@bioprotect.com or call 610-317-1670
