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Physicians

Reproducible, Visible, Defined Space

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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

FAQ

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.

 

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