Overview
 Next-Generation, Dual-Action Thermodilatation, Minimally Invasive Therapy for BPH Symptoms

The Prolieve™ Thermodilatation System is the next generation in minimally invasive BPH symptom treatment. This dual-action thermodilatation technology simultaneously heats the prostate while dilating the urethra. The treatment is well tolerated by patients and most patients do not require post-treatment catheterization.

The Prolieve System is made up of a microwave, computer, and a single-use Prolieve System Procedure Kit. The device delivers microwave energy (heat) to the prostate for the treatment of symptomatic BPH in men with a prostate size of 20 to 80 grams, a prostatic urethra length between 1.2 cm and 5.5 cm and in whom drug therapy (e.g., Proscar® [Finasteride]) is typically used.

The device uses a microwave antenna that is inside a transurethral catheter, which is placed inside the urethra to heat the prostate. At the same time, a balloon on the catheter inflates and pushes against the wall of the urethra.

A heat-exchanger cartridge is responsible for warming fluid that circulates through the balloon catheter. A rectal temperature monitor is placed in the rectum near the prostate to monitor temperature. The heating process is controlled by a computer in the machine that reads the temperature measured by the rectal temperature monitor.

Procedure
The physician and the technician prepare the Prolieve System for use according to the instructions in the Prolieve System User Manual. A topical aqueous-based anesthetic will be applied to the opening of the urethra, a catheter will be inserted into the bladder and different methods, such as x-ray or ultrasound, may be used to verify the exact location of the equipment.

A temperature monitor with a prophylactic cover will be inserted to monitor the treatment. Heat generated by microwave power and compression by the transurethral catheter balloon will be applied to the prostate gland. The catheter and temperature monitor will be removed at the conclusion of the treatment. The preparation and the procedure should take approximately 60 to 90 minutes.


      Figure 1:
This is a schematic illustration
of a cross section of a prostate
BEFORE treatment with The
Prolieve Thermodilatation System.

Figure 2:
This is a schematic illustration
 of the proper internal position
of The Prolieve Thermodilatation System balloon catheter in the prostate.

Figure 3:
This is a schematic illustration
of a cross section of a prostate immediately AFTER treatment
with The Prolieve Thermodilatation System.