Request to continue Minerva Trial:

Procedure Description:

Minerva is the first entirely new endometrial ablation technology introduced in the last 19 years and uses a novel mechanism of action, plasma thermal conduction, over a two-minute treatment cycle to ablate the lining of the endometrium.

Advantages:

Patient Safety

Proprietary safety features include:

• Visual confirmation of cervical seal prior to safety check
• CO2 extension tubes designed for greater sensitivity in detecting perforations
• Maximum 40 watts of energy delivery modulated by real time impedance monitoring vs maximum 180 watts of constant power delivery

Efficacy

In comparison to the nearest competitor, Minerva demonstrated the following in FDA trials:

• Highest amenorrhea rate – 72% vs 36%
• Highest long term success rate – 93% vs 76%
• Lowest long term hysterectomy rate – 0.91% (1 total) vs 6.3% (11 total)
• More effectively treats patients with a uterine sounding length greater than 6 cm

Ease of Use

• Silicone array which inserts and removes easily
• Intracervical sealing balloon
• Visual touchscreen interface
• Total procedure time was 3+ minutes, 40% faster than the next fastest treatment.

We the undersigned wish to continue the trial of the Minerva endometrial ablation system at The Woman's Hospital of Texas for the reasons stated above.