Patients who may benefit from TherMatrx® include men who are not satisfied with the results or side effects of their current treatment choice; those interested in a one-time, non-surgical treatment; and those concerned about sexual side effects.

Patient Selection

Patients with the following criteria have the best opportunity for fast symptom relief 1 and long-lasting symptom relief: ^{1, 2}

• Duration of BPH longer than 3 months
• Veru length to Bladder Neck at least 2.5 cm
• American Urology Association (AUA) symptom score > 12 or Madsen symptom index > 8
• Peak flow rates < 15 cc/sec on a voided volume > 125 mL
• Post Void Residual (PVR) > 200 mL
• Total prostate volume of 30-100 grams

The patient's medical record must include the signs and symptoms exhibited by the patient with the results of the testing performed to support and demonstrate that the treatment is reasonable and necessary. Documentation must be available, upon request, for review by the Medicare carrier.

Contraindications/Exclusion Criteria

TherMatrx is contraindicated in patients with:

• Severe urethral strictures, preventing easy catheterization
• Implanted defibrillators, pacemakers, or any other active implant
• Penile or urinary sphincter implants
• A metallic implant in the prostatic treatment area, pelvis, or hip
• History of prior radiation therapy to the pelvic region
• Peripheral arterial disease with intermittent claudication or Leriches syndrome
• (i.e., claudication of the buttocks and perineum)
• A minimum prostatic urethra length < 25 mm and a total prostatic volume between of < 30 or > 100 grams.

Precautions

The safety and effectiveness of the TherMatrx TMX3000 system has not been established in patients with the following conditions:

• Interest in preserving future fertility
• Coagulation disorders
• Renal implantation
• Neurological disorders which may affect bladder function
• Post void residual volume of > 200 mL
• Urinary retention requiring indwelling catheter
• Large median lobe of the prostate protruding into the bladder
• Active urinary tract infection
• Bacteriological evidence of bacterial prostatitis
• Bladder stones, previous pelvic surgery
• Previous rectal surgery (other than hemorrhoidectomy)
• Prostatic urethra lengths > 57 mm in length
• Clinical or histological evidence of prostate or bladder cancer

Proceed with caution when treating patients with any conditions listed above.

For a complete list of indications, contraindications, warnings and precautions, refer to the TherMatrx Instructions for Use or contact your AMS representative.

1. Transurethral Microwave Thermotherapy System. TherMatrx TMx-2000™. PMA P000043 summary of safety and effectiveness data. Approved June 29, 2001. Available at: www.fda.gov/cdrh/pdf/p000043.html.

2. Albala D, Andriole G, Davis B, Eure G, Kabalin J, Lingeman J, Nuzzarello. Transurethral microwave thermotherapy (TUMT) using the TherMatrx TMX-2000^a for treatment of benign prostatic hyperplasia: 5-year follow-up of multicentre randomized pivotal trial. Eur Urol Apr 2006;5(2 suppl.):234 abstract 846.