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The Thermoflex system is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia ("BPH"). It is indicated for use in men over the age of 50 years with prostate lengths between 2.0 cm and 6.4 cm who present symptoms of urinary outflow obstruction secondary to BPH.

The Thermoflex system is a catheter based thermal therapy device for the treatment of symptoms due to urinary outflow obstruction secondary to BPH. The Thermoflex system combines a heating console/pump with a sterile, multiple balloon WIT prostatic catheter. Following insertion of the WIT prostatic catheter into the bladder through the urethra, a "locating" balloon is filled with a small volume of air and positioned within the bladder neck to insure proper placement of the treatment balloon within the prostate. A predetermined volume of water is added to the balloon dilation catheter ("treatment balloon"), causeing the treatment balloon to dilate within the prostate, creating pressure and insuring contact of the treatment balloon's surface with the prostatic tissue. Water is heated externally to the body and pumped through the thermally insulated catheter to the treatment site and back to the heating console/pump. At the treatment site, heat from the water is exposed to the urethra and prostatic tissue by means of physical contact of the treatment balloon with the target tissue. Heat from the water is transferred conductively to the tissue, inducing tissue ablation due to coagulation necrosis and tissue devitalization.