The BioProtect ProSpace is implanted in a quick and minimally invasive transperineal approach procedure using a proprietary insertion device under local anesthesia. The ProSpace is inserted as a folded cylinder. Once the folded balloon is placed between the prostate and the rectum, the balloon is inflatied with sterile saline and deployed to gain its final configuration.
By having the BioProtect ProSpace implanted between the prostate and the rectum, a space is created between tumor and healthy tissue, thereby reducing radiation exposure to the rectum during radiation therapy. Instead of a separation distance of only few mm, BioProtect creates a “safe gap” of 15 to 20 mm.
* Disclaimer: The BioProtect ProSpcae is approved for marketing in Europe as of October 2010and is under clinical investigation and is not approved yet for marketing in the USA. For the USA, this material should be considered informational only and does not constitute an offer to sell in any juridiction in which this product is not yet permitted to be sold in the USA.
The BioProtect ProSpace remains in the body during the wide span radiation period at different centers, after which time it naturally biodegrades within 3 to 6 months post implantation.