TherMatrx® has proven safety and efficacy with 5-year durability data. 1
Proven safe
- No long-term side effects or adverse events reported in PMA clinical study office 2
- Post-treatment side effects like bladder spasms or hematuria were generally transitory, minor and self-resolving office 2
Proven effective
- In clinical studies, patients showed 47.1% improvement in their AUA
symptom score and 58.1% improvement in Peak Flow Rate office 2
Exceptional patient tolerance
- Only mild oral medications are needed for excellent patient tolerance and comfort during treatment office 2
Minimal sexual side effects
- Less than 1% of patients reported cases of erectile dysfunction office 2
The following were NOT seen in the TherMatrx clinical study for FDA approval 3
| |
Rate of Incidence |
| Rectal damage/fistula |
0% |
| Urinary infection |
0% |
| Retrograde ejaculation |
0% |
| Painful or difficult ejaculation |
0% |
| Loss of ejaculate or decreased fluid volume |
0% |
| Sphincter damage |
0% |
| Urethral strictures |
0% |
1. Albala, et al, Transurethral microwave thermotherapy (TUMT) using
the TherMatrx TMX-2000™ for treatment of benign prostatic hyperplasia:
Five year follow-up of multicenter randomized pivotal trial. Data on
file at AMS.
2. TherMatrx-2000 BPH Thermotherapy System. P000043. FDA Approved 6-29-01. Summary available at: www.fda.gov/cdrh/pdf/P000043.html.
3. 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.
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