The Trans-Urethral Catheter (TUC) Safety Valve is a unique and innovative patented technology. It is a Class I, sterile, single use medical device and as such has a simple regulatory pathway of self assessment. The competition Class Medical is facing is that of training, however, for over 80 years catheters have been placed, training initiatives are run constantly and injuries are still occurring. The crux of the issue is that this is a blind medical procedure and as such it is impossible to be 100% confident that the catheter balloon is in the bladder and not the urethra, hence, the need for a safety device.
Current approaches offer no real alternative to the TUC Safety Valve. Class Medical’s 2015 Journal of Urology publication demonstrates that procedural training programs have failed to reduce incidence rates significantly as Foley catheters have been around for over 80 years and still the issue occurs. The incidence rates of patient injury ranges from 1.3% to 7.0% which indicates that this is a serious issue and one that needs to be resolved.