BioProtect Balloon Implant – Protecting Healthy Tissue during Prostate Radiation Therapy; Enabling Hypofractionation and SBRT
The BioProtect Balloon Implant is indicated for prostate cancer patients undergoing radiation therapy. The biodegradable balloon separates the prostate and rectum, allowing physicians to radiate prostate tumors while sparing healthy rectal tissue. With the balloon implant, safe dose escalation and hypofractionation are finally made possible, dramatically decreasing the chances of rectal toxicity and improving biochemical tumor control.
Comparison of two different rectal spacers in prostate cancer External Beam Radiotherapy in terms of rectal sparing and volume consistency:
Visibility of the balloon under Ultrasound, CT and MRI:
The BioProtect will be available for reimbursement from SEPTEMBER 2017!
“.. The balloon provides a better, more consistent separation as it has a defined shape, deployment is easier with no time limit, while with the gel you have only 8 seconds before it solidifies and clogs the needle. The balloon is a dynamic and reversible spacer whose volume may be adjusted during the procedure, while with the gel there is no control.” – Dr. Stefan Machtens, Marian Hospital, Bergisch Gladbach, Germany.
“.. The balloon is easier to deploy and a better product overall. With the gel I had a couple of cases in which the material was injected into the rectal mucosa.” – Dr. Stefan Hruby, SALK and Paracelsus Medical University, Salzburg, Austria.
“.. The balloon is more convenient to use, mainly because there is no time limitation, and due to its better visibility under TRUS.” – Dr. Schultz (RT) and Dr. Ulmann (Urologist), Ernst-von-Bergmann Clinit, Potsdam, Germany.
“.. I experienced some problems with the gel. With one patient, it went through the bladder. I could not see exactly where I was injecting it.” – Dr. Cussoto, Cardinal Massaia Hospital, Asti, Italy.
“I would say the device provides capability to significantly reduce the dose to the rectum, which should provide an added margin of safety beyond what can be achieved by even the most sophisticated radiation delivery techniques.” – Mitchell S. Anscher, Professor and Chair, Department of Radiation Oncology, VCU School of Medicine, Virginia, USA.
“I experienced and implanted BioProtect’s biodegradable balloon device. The implantation procedure is easy to learn and to perform. Our implanted patients were very satisfied having no post-implant side effects. From a radiation therapy treatment point of view, there is a clear benefit in terms of enlarged distance between the dorsal part of the prostate and the ventral rectal wall.” – Gyoergy Kovacs M.D., Professor of Radiotherapy & Head Interdisciplinary Brachytherapy Unit, University of Luebeck, Germany.
Radiation Treatment for prostate cancer might cause severe side effects to organs at risk such as the rectum. In this video Dr. Vanneste from Maastro Clinic in Maastricht, Netherlands, describes the implantation of BioProtect’s Balloon Implant System into the perirectal space between the prostate and the rectum.
Prostate cancer is prevalent among men over fifty. BioProtect’s balloon spacer protects healthy tissue from the harmful affects of radiation treatment.
Recent studies have shown improved quality of life and improved sexual function in men who were protected by a spacer during radiation treatment. The following video describes the product in more detail: