Can anyone give me an inside view of Minerva Surgical and is it truly cutting edge in this space? Thanks in advance!
Minvera technology does not work and is missing key safety features.
Take the following into consideration.
Uniform depth ablations:
0) HerOption Cryo, 1-2mm (reason IUDs did a better job at amenorrhea)
1) Thermachoice = 2-3mm depth (contained in a balloon = safe, but treatment heat sync lacks)
2) HTA (same temperature as Thermachoice, but had 2 extra minutes of treatment time), average depth is 3-3.5mm. Company tried increasing time to improve heat sync, but it actually caused adverse events in this process on extirpated uteri. Therefore, it is known in the world of endometrial ablations that if you are a uniform technique you can only safely go 3.5mm.
3) Minerva, uses RF to trigger heat in a plasma filled balloon. The balloon does not distend to the inner walls of the tissue like Thermachoice did (probably less cramping, but less coverage). The remaining effect of the Minvera is to allow steam to create a contoured uniform depth of ablation of 3.6mm.
3 Big concerns here:
First) If everyone thought hot water was unsafe, steam is definitely not safe if it is not monitored, or controlled. The company will have you believe that they monitor the steam or integrity of their balloon; yes that is true, but only up until the point prior to treatment. Once treatment starts, THERE is ZERO monitoring of the balloon, at that point the therapy will continue until completed 2 minutes later. If in the event there is an escape of steam it could travel to areas of the body not intended. Also, there is potential that if there was a perforation during sounding of the uterus the balloon could present issues with a false negative. Thus, allowing a channel for steam to go outside of the uterus into the peritoneal cavity, aka near bowel. This is all without an integrity in their balloon failing.
Second) 3.6mm is not deep enough on the side walls and too deep near the corners of the triangle.
Third) Many areas of the uterine cavity remain untreated due to the lack of contact with steam and/or the balloon.
4) NovaSure - here is why it is still the best almost 20 years later.
- Only tapered endometrial ablation 2-3 mm in corners 5-7 on the side walls.
- Safety monitoring during treatment, if issue with moisture (steam removal) machine automatically shuts off each time asking team to troubleshoot any potential leaks. If after a series of the same issue it is know with every restart of the treatment that there is probably a real issue, therefore the therapy is aborted entirely.
- NovaSure has 9 out of every 10 cars on the road, it is statistically superior to all therapies.
- NovaSure has been studied and does not mask the risk of cancer
- NovaSure works very well post-myoma (fibroid) polyp resection, it will cauterize any areas of bleeding
- 75% no bleeding at 5 years