The Combat BRS System is an innovative bladder recirculation system designed to deliver.
Combat BRS is an innovative bladder recirculation system for the treatment of non muscle invasive bladder carcinomas (NMIBC) with thermotherapy and cytostatic agents such as Mitomycin C, Epirubicin, etc.
The patented system allows an effective heat exchange with a constant temperature of 43 0.5 °C, constant pressure and volume flow during the entire treatment period and, for the benefit of the patient, the use of a slim 16 Fr catheter.
Successful in clinical use since 2011, it is safe for patients and medical staff and has a comparable patient tolerability to bladder instillation at room temperature.
Several ongoing clinical studies are aimed at demonstrating the clinical evidence of Hyperthermic Intra-VEsical Chemotherapy (HIVEC™):
HIVEC-I HIVEC-II
Prospective, Randomised International Multicentre Clinical Trials in 598 Intermediate Risk NMIBC Patients. HIVEC-I and II have successfully completed recruitment with data release expected in early 2020.
HIVEC-HR HIVEC-R HIVEC-Premito
Further trials encompassing 269 patients are currently evaluating the efficacy of HIVEC at various stages of the NMIBC treatment pathway.
The patented aluminium heat exchanger in combination with the temperature measurement immediately before entering the body allows a constant precise set temperature with a minimum fluctuation of ±0.5 °C during the entire treatment period.
This guarantees a homogeneous drug and heat distribution throughout the entire bladder, prevents punctual, unwanted temperature peaks on the bladder wall and allows contact-free removal of the medication for safe disposal.
The Combat BRS System is portable, robust and easy to use. Simple to integrate into current treatment practice it requires minimal set up, no continuous monitoring and therefore minimal additional resources either physically, logistically or financially.
Both the BRS system and disposable sets are affordable and through improving patient outcomes, the overall treatment cost can be reduced.
The Combat BRS System harnesses accurate and effective heat control and the proven synergistic effects of chemo-hyperthermia to target NMIBC.
The mutually enhancing effects of chemotherapy drugs and hyperthermia are well documented for their cytotoxic effects and are widely used in treating several types of cancer including bladder cancer. Cancer cells become more permeable and are increasingly affected on many levels because of their inability to dissipate heat while the heat enhances the body’s natural immune responses.
The Combat BRS system monitors temperature and pressure throughout the treatment. Acoustic and visible warnings as well as automated cut off on exceeding or falling below threshold values ensure patient safety and comfort.