Medical Professionals

Cooled ThermoTherapy™

Give Him a Lasting Solution

Microwave Therapy For BPH That Allows You To Customize Treatment And Provide:

• Long-term durability¹
• Patient comfort¹
• Variable energy settings
• Treatment of the broadest patient population, including retention patients²

¹Cooled ThermoCath (CTC) paired data from US IDE Study G010040 (07/06) Data Lock April 2007.
²Data on file at Urologix MC1323 indication comparison for Cooled ThermoTherapy™, Prolieve^® and TherMatrx^®

Clinical Results

Cooled ThermoTherapy™ Long Term Results Presented at AUA 2008
Durable relief after five years from symptoms of enlarged prostate

Long-term clinical results from a multi-center trial with the Cooled ThermoCath® (CTC) Microwave Catheter for the treatment of benign prostatic hyperplasia (BPH), also known as enlarged prostate, was presented at the 2008 American Urological Association meeting in Orlando, Florida.

The results showed the efficacy of the CTC Microwave Catheter is durable for up to five years and freedom from additional minimally invasive or surgical procedures is 90%. The data from the study showed clinically significant improvement from baseline of the three major BPH evaluation criteria: urinary flow rate, symptom improvement, and quality of life at the 5-year follow-up.

Please click the image below to review the scientific poster presented.

For complete indications, contraindications, warnings, precautions and instructions for use, please visit our Products page on this web site.

Cooled ThermoTherapy™ produces durable improvements in symptoms, quality of life and flow rates to at least 5 years after treatment.¹

All of the following clinical data has been extracted from the Journal of Urology’s publication entitled, “Cooled ThermoTherapy for the treatment of Benign Prostatic Hyperplasia: Durability of results obtained with the Targis System.” by Paul D. Miller, Christof Kastner, Ernest W. Ramsey and Keith Parsons.¹

Quality of Life (QOL) Score Quality of life was measured by asking patients, “If you were to spend the rest of your life with your prostate symptoms just the way they are now, how would you feel about that?” Responses ranged from delighted to terrible. (score 0-6)

International Prostate Symptom Score (IPSS) aka: AUA Symptom Score
Improvement – How is it measured?

• Marked – Decrease of 13 points or more
• Moderate – Decrease of 7 – 12 points
• Slight – Decrease of 3-6 points
• No – Decrease of 0-2 points

At 5 years, 82% showed moderate or marked improvement in AUA symptom score.

Peak Flow (QMax) At 5 years, the peak flow rate improvement is statistically significant. Approximately 47% of patients are still experiencing a 50% increase in peak flow rate at 5 years. At least an 80% increase in peak flow rate was seen in 26% of patients at 5 years.

¹Miller, Paul D., et al, Cooled ThermoTherapy for the Treatment of Benign Prostatic Hyperplasia: Durability of Results Obtained with the Targis System, Urology, Vol. 61, No. 6, June 2003.

Prescriptive Information

Indications:
The Targis^® system is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH).

Targis System Description:
The Targis system is comprised of a Control Unit which produces the microwave energy and monitors all aspects of the Cooled ThermoTherapy™ procedure, a Microwave Catheter which delivers the microwave energy to the targeted prostatic tissue, an RTU which measures rectal temperatures during the Cooled ThermoTherapy procedure and a Coolant Bag which provides a reservoir of sterile coolant water to the Microwave Catheter. The Targis system treats BPH by applying microwave power to the prostate, and continuously heating the diseased tissue via transurethral catheter. It also minimizes patient discomfort and risk to the urethra by circulating cooling fluid through the Microwave Catheter.

Contraindications:
Patients with a prostatic urethra<2.5 cm in length, measured from the bladder neck to the verumontanum. Patients with urinary sphincter or any implant (metallic or non-metallic) which is within 1.5 inches (38 mm) of the prostatic urethra. Patients with urethral stricture (unable to pass 22 F urethroscope). Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e. claudication of the buttocks or perineum). Patients who have undergone pelvic radiation therapy. Patients with implanted active devices, including pacemakers or defibrillators, within 2.6 inches (6.5 cm) of the prostatic urethra. For patients with active implanted devices located greater than 2.6 inches (6.5 cm) from the prostatic urethra, it is recommended that non-cardiac devices be turned OFF during treatment with the Targis system, if possible(e.g. active implanted devices used in the treatment of pain or incontinence), to lessen the likelihood of adverse interaction caused by electromagnetic interference.

Warnings & Precautions
Only those physicians who have been thoroughly trained on the operation of the Targis System and the Cooled ThermoTherapy procedure should deliver the Cooled ThermoTherapy procedure. The Targis system and components should not be used in any way other than the intended and indicated use and according to the Instructions for Use. The Cooled ThermoTherapy procedure must not be initiated without assurance that the Microwave Catheter is properly positioned in the patient. The Cooled ThermoTherapy procedure must not be initiated until an enema has been given and the RTU is properly placed into the patient’s rectum and inflated. It is important that the patient not be over sedated. This may compromise his ability to communicate pain. All components of the Targis system must be used in a manner consistent with the instructions set forth in their respective Instructions for Use insert and the Targis System User Manual. Failure to do so may result in insufficient treatment or increased risk of injury or infection to the patient.

Potential Adverse Effects
The following complications have been observed: post-treatment catheterization, mild hematuria, dysuria, clots in urine, temporary or partial ejaculate loss, pain or irritation in the groin or pelvis, bladder spasms, hemospermia, prostatic urethra damage, rectal irritation, temporary acute incontinence, interrupted flow, sensation of not emptying bladder, bladder trabeculation, severe pain during treatment, pain or discomfort during sexual activity, frequency, hesitancy, urgency, post-void dribbling, blood pressure changes during treatment, hospitalization in general related to treatment, transient erectile dysfunction, urinary tract infection, complete loss of ejaculate, bladder diverticali, weak stream, erectile dysfunction, epididymitis, prostatitis, nocturia, urethral stricture, and rectal fistula.

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

View the complete Instructions for Use.

Publications

Web site Clinical References

Since 1991, Urologix’ strong reputation for scientific integrity has been supported by extensive basic science. Nearly 200 peer-reviewed clinical articles and presentations support the efficacy and safety of our products and our consistent clinical results.

Our clinical outcomes represent more than 2,200 patients treated with Cooled ThermoTherapy™ at many of the world’s leading medical institutions.

The following is a sampling of articles:

Peer Reviewed Journal Articles

Durability and General Efficacy

Long-Term Pooled Analysis of Multicenter Studies of Cooled Thermotherapy for Benign Prostatic Hyperplasia: Results at Three Months Through Four Years. Trock, M., et al., Urology, 63 (4) pp 716-721 April 2004 B.

Cooled Thermotherapy for The Treatment of Benign Prostatic Hyperplasia: Durability of Results Obtained with the Targis System. P. Miller, et al., Urology, 61 (5) pp. 1160-1165 June 2003.

Transurethral Microwave Therapy in 200 Patients with a Minimum Follow-Up of 2 Years: Urodynamic and Clinical Results. G. Thalmann, et al., Journal of Urology, Vol. 167, 2496-1502, June 2002.

A High Efficiency Microwave Thermoablation System in the Treatment of Benign Prostatic Hyperplasia: Results of a Randomized, Sham-Controlled, Prospective, Double-Blind, Multicenter Clinical Trial. T. Larson, et al., Urology, 51 (5), 731-742, June 1998.

A Novel Transurethral Microwave Thermoablation System to Treat Benign Prostatic Hyperplasia? Results of a Prospective Multicenter Clinical Trial. E. Ramsey, et al., The Journal of Urology, vol. 158, 112-119, July 1997.

Cooled ThermoTherapy vs. Medical Management

Targeted Transurethral Microwave Thermotherapy versus Alpha-Blockade in Benign Prostatic Hyperplasia: Outcomes at 18 Months. B. Djavan, et al, Urology, Vol. 57(1) pp. 66-70, January 2001.

Cost Consequences of Surveillance, Medical Management or Surgery for Benign Prostatic Hyperplasia. T. Chirikos, E. Sanford, Journal of Urology Vol. 155 (4) April 1996

Interstitial Temperature Mapping

Detailed Interstitial Temperature Mapping During Treatment with a New Transurethral Microwave Thermoblation System in Patients with Benign Prostatic Hyperplasia. T. Larson, J. Collins, A. C—rica, Journal of Urology, vol. 159, 258-264, January, 1998.

Urinary Retention

Efficacy of High-Energy Transurethral Microwave Thermotherapy in Alleviating Medically Refractory Urinary Retention Due to Benign Prostatic Hyperplasia. D. Kellner, et. al. Urology 64 (4) pp. 703-706, October 2004.

Transurethral Microwave Thermotherapy (TUMT) with the Targis System: A Single-Centre Study on 78 Patients with Acute Urinary Retention and Poor General Health. A. Berger, et al., European Urology 43 (2003) pp. 176-180

Microwave Thermotherapy in Patients with Chronic Urinary Retention. B. Djavan et. al., Techniques in Urology, 6(4), 278-281, December 2000.

High-Energy Transurethral Microwave Thermotherapy in Patients With Acute Urinary Retention Due to Benign Prostatic Hyperplasia. B. Djavan, C. Seitz, K. Ghawidel, A. Basharkhah, B. Bursa, S. Hruby, and M. Marberger, Urology, vol. 54 (1), 18-22, July 1999.

Abstracts

Cooled ThermoCath^® Microwave Catheter

Continuing Results of a Multi-Center Trial of a New Generation Cooled TUMT for Benign Prostatic Hyperplasia, L. Mynderse, C. Roehrborn, et al. Presented at the 2007 AUA Annual Meeting.