Summary of warnings, precautions and contraindications for TherMatrx Office Thermo Therapy:

• This device is contraindicated in patients with intermittent claudication, urethral strictures, active implants, urinary sphincter implants, or metallic implants in the prostatic treatment area, or patients with a minimum prostatic urethra length < 30mm and a total prostate volume < 30 or > 100cc.
• The TherMatrx System and components should only be used as intended and indicated in the Instructions for Use. Failure to do so could result in compromised patient safety and/or insufficient therapy.
• Failure to properly position the Treatment Catheter could result in heating and severe injuries outside the treatment area. If catheter placement is in question, verify placement by ultrasound imaging after inflating the balloon. Inflation of the balloon with more than 5 cc of sterile water may position the catheter too high in the urinary channel which may result in heating outside of the treatment area.
• The TherMatrx procedure has inherent risks of complications, though reported adverse events have been minor and self-resolving.

For a complete list of indications, contraindications, warnings and precautions, refer to the TherMatrx Instructions for Use.