Prostiva RF Ablation System

What It Is

The system is comprised of an RF generator, rod lens telescope, and a disposable hand piece.

The dual channel generator produces RF energy at 473 kHz (+/- 2 kHz sinusoidal unmodulated), which is applied to prostatic tissue to create a localized, coagulated necrotic lesion.

Generator Model 8930001

This portable, line-powered, dual channel generator is capable of producing up to 15 watts (W) per channel. The RF generator performs 15 safety checks to ensure a safe outcome. The safety checks provide constant monitoring of the procedure from start to finish, including:

• Measures intra-prostatic and urethral temperature 11 times per second and urethral temperature 6 times per second to ensure proper prostatic ablation and safety for the urethra
• Calculates and displays needle length setting for hand-piece, based on patient's transverse prostate measurement
• Displays urethral temperature and directs you to irrigate the urethra when necessary
• Alarms at 43° C and automatically turns off at 47° to protect the urethra from overheating
• Displays time remaining for each treatment site

Rod Lens Telescope Model 8099TU/15

The telescope features autoclave sterilization and either 0° or 15° viewing angle. You can directly visualize anatomical landmarks and treatment sites in real time:

• Enables precise needle placement under direct visualization
• Works with most medical-grade video camera systems and light sources

Handpiece Model 8929001

The hand piece is a single-use device designed to work with the Prostiva RF Generator and Telescope to provide precise necrosis:

• Complete sterile assembly
• Two insulated needles
• Six needle length adjustments
• Integrated RF cable
• RF activation switch
• Irrigation system
• Return Electrode (grounding pad)

How It Works

With the Prostiva^® Radio Frequency System, radio frequency (RF) energy is delivered via two electrodes into the prostate tissue for selective ablation of specific areas.

Thermal ablation occurs through a combination of RF energy and the inductive heating of water molecules in the tissue. The theory is that the process devascularizes and denervates the prostatic tissue, which may result in BPH symptom relief and improved urine flow.

Normal Prostate	Enlarged Prostate
During the Procedure	After the Procedure

Precise Necrosis

In MRI images, you can see exactly where the RF energy caused tissue necrosis.

Larson, Thayne. Institute of Medical Research and Lance Mynderse, M.D., Mayo Clinic. “MRI study of 12 patients with average age of 64, treatment focus on bladder neck and lateral lobe,” 2006 Medtronic RF Therapy Study.