New Data Presented at ESTRO 37 highlight the efficacy and safety of the BioProtect Balloon Implant® Spacer
Studies show the BioProtect biodegradable spacer provides significant reduction in rectal dose throughout the radiation treatment for prostate cancer, in IMRT, SBRT and Brachytherapy, while providing clinical advantages such as reproducibility and reliability.
BioProtect Ltd. announced today that studies on the clinical use of the leading-edge BioProtect Balloon Implant® continue to demonstrate its benefits across different radiation modalities such as brachytherapy, SBRT and extreme hypofractionation.
4 European studies were presented during poster and oral sessions at the 37th Annual European Society for Radiotherapy & Oncology (ESTRO) Meeting in Barcelona, Spain, April 20-24, 2018. All studies demonstrated excellent efficacy and safety of the BioProtect Balloon.
The BioProtect Balloon Implant is used worldwide for effective reduction of rectal radiation dose in prostate cancer radiotherapy.
- A study conducted in Mount Vernon, UK, reported the first use of a biodegradable balloon spacer device for high dose rate prostate brachytherapy in 2 patients. The balloon implantation only increased the duration of brachytherapy procedure by a few minutes, was well-tolerated with excellent dose distribution achieved.1
- Two separate studies used the balloon spacer in SBRT extreme hypofractionation regimes in 24 patients. No complications or side effects were observed due to the placement of the balloon spacer. The research was conducted at CUF instituto in Porto, Portugal, and another in the university hospital in Lausanne CHUV, Switzerland).2,3
- Another study compared the anatomical and radiological parameters 3 spacers for prostate cancer radiotherapy. Out of 46 patients, 16 received the BioProtect biodegradable balloon, 19 were injected with hyaluronic gel, and 11 with PEG hydrogel. This MRI study conducted by Clinique Pasteur in Toulouse France, confirmed the opportunity of creating a good space between prostate gland and rectum with an excellent implantation profile.4
- Alonzi et al., The first use of a biodegradable balloon spacer device for high dose rate prostate brachytherapy Radiotherapy and Oncology – J. ESTRO 37 Volume 127 suppl.1 (2018)
- Costa et al. Balloon Device for Prostate Cancer SBRT – Increased Spacing helps to Overcome Rectal Toxicities Radiotherapy and Oncology – J. ESTRO 37 Volume 127 suppl.1 (2018)
- Herrera et al, Prostate cancer SBRT dose escalation to the dominant nodule/s: Phase I and immunological effects Radiotherapy and Oncology – J. ESTRO 37 Volume 127 suppl.1 (2018)
- Latorzeff Bruguier et al, Comparison of patterns of implantation for the 3 spacers for radiation therapy for prostate cancer. Radiotherapy and Oncology – J. ESTRO 37 Volume 127 suppl.1 (2018)
The BioProtect Balloon System provides benefits in GI and rectal dose reduction in prostate cancer radiotherapy
The BioProtect Balloon Implant is a biodegradable polymer balloon spacer designed to safely and temporarily separate the rectum from the prostate during prostate cancer radiation therapy. Rectal radiation exposure is a major limiting factor in prostate radiation oncology and a cause for acute and chronic rectal toxicity, manifested in rectal pain and bleeding. The biodegradable balloon is designed for trans-perineal implantation.
“We are addressing a major limiting factor in prostate cancer radiotherapy which is complications of bowel function and rectal toxicity associated with radiation exposure to the rectum due to its proximity to the prostate. With advanced radiation technologies, and higher cancer survivorship, long term side effects of radiation, especially pelvic radiation disease or gastrointestinal injury, have come into the spotlight. This challenge is clinically relevant in all radiation modalities.” said Israel Birenbaum, BioProtect CEO.
For the full ESTRO37 abstract book click here