Request for Minerva Product Trial

Procedure Description:

Minerva is the first entirely new endometrial ablation technology introduced in the last 17 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

We the undersigned wish to trial the Minerva endometrial ablation system at Novant Health for the reasons stated above.