Every patient will receive a 120 second treatment cycle, however the amount of energy delivered during the 120 seconds will vary from patient to patient depending on uterine cavity size and thickness of the endometrium. Each ablation starts with a maximum of 40W of power and declines over the course of the ablation as the impedance within the cavity increases.
Minerva ES does not rely solely on direct tissue contact to achieve optimal ablation. Three simultaneous and complementary methods of tissue ablation are being employed by Minerva, providing a truly global ablation.
Minerva ES is the only ablation system that modulates the power level over the course of the ablation cycle. The controller adjusts power in real time by assessing the changes in the state of the uterine cavity during the ablation process, with measurements being taken and adjustments made 50 times per second. During the ablation process, the area of unablated tissue decreases, and power starts dropping accordingly, with plasma being redirected. Thus focusing ONLY on the least ablated endometrium for a uniform surface area coverage and depth of ablation.
Plasma is another term for ionized gas, in this case argon. The argon gas inside the membrane is ionized by the RF energy delivered to the handpiece from the Minerva Controller.
The cervix should be dilated. An 8mm Hegar dilator is included in the device packaging. The dilator has graduated length markings to ensure accurate measurement of the cervix.
Do not turn off the Controller. Most error codes may be resolved via troubleshooting or replacing the device. Then the Controller will proceed through the safety checks and resume and ablate for the remaining treatment time. In rare instances, a hard fault may be encountered that would require cycling off power to the Controller. Consult the Operator’s Manual or call Minerva for more information.
A maximum of 2 times. If more inflations are needed, reassess to make sure the device is properly positioned in the uterine cavity and rule out uterine perforation.
In a controlled clinical study conducted for a FDA approval, Minerva ES achieves an Amenorrhea rate of 72%, or 7 out of 10 women.
Minerva has a low hysterectomy rate, with only 1 out of every 100 patients requiring hysterectomy at 3 years, compared to 6 out of every 100 patients for the closest competitor.
According to the FDA, hysteroscopy is optional when performing endometrial ablation.
The argon cartridge will last for approximately 7 treatments. A CO<sub>2</sub> cartridge will last for approximately 25 treatments.
<strong>No.</strong> According to the product labeling, the use of Minerva ES, and all other second-generation endometrial ablation technologies, is contraindicated in a patient with any anatomic condition that could lead to weakening of the myometrium. Please consult instructions for use for complete indications, contraindications, warnings and precautions.
The Minerva treatment should not be performed concomitantly with the placement of the Essure device. The safety and effectiveness of the Minerva treatment has not been evaluated in patients with the Essure device.
Can Symphion be used for both polyps and fibroids? If so, are there multiple resection device sizes?
Yes. Symphion is indicated for resection of any intrauterine tissue. By design, there is only one resection device size, which is independent of the type and size of pathology for a more streamlined, cost effective and minimally invasive solution for treatment of AUB due to structural causes.
Symphion utilizes RF plasma cutting / coagulation technology for fast tissue resection without dull blades that are often seen in older cutting technologies.
Symphion is designed to volumetrically limit the amount of distention media that potentially can be absorbed, and this value will never exceed 2,500 mL. This is achieved via Symphion’s “closed loop” fluid management system. The re-circulating distention media allows the user to calculate the fluid loss by simply subtracting the remainder of fluid in the 3L saline bag from the operating volume of 2,500mL.
Total Fluid Loss equals 2500mL minus Amount of saline remaining in 3000mL bag (approximately 500mL remain in the system)
No. Symphion uses bladeless RF plasma resection technology. As a result the device does not dull or weaken during treatment.
Symphion has an independent aspiration mode.
Histologic evaluation of the tissue chips indicates a consistent depth of tissue thermal effect limited to ~ 80 microns.
No. The Symphion Fluid Management Accessory (FMA) is all-inclusive.
3.0mm diameter or smaller diagnostic hysteroscope can be used with the corresponding adapter.
Yes. To order, contact Minerva Customers Service at 855-646-7874.
Genesys HTA operates between 50-60mmHg of pressure.
Target temperature is 90 degrees Celsius and will fluctuate several degrees during the treatment cycle
Yes. Only use normal saline (0.9%).
Do you need to use a different scope or scope setup for diagnostic hysteroscopy before doing a Genesys HTA ablation?
You can use a single scope in conjunction with the Genesys HTA setup. No additional or separate setups are required.
Resectr comes in two sizes:
5Fr outer diameter, 5mm cutting window, 35cm length
9Fr outer diameter, 7.5mm cutting window, 35cm length
The 5Fr Resectr may be used with any hysteroscope that has an operative channel of 5Fr or larger. The 9Fr may be used with any hysteroscope that has an operative channel of 9Fr or larger.
No. Resectr is a handheld device that is powered by squeezing the handle of the device. No external power source is needed. A source of suction (wall or pump) is required.
The Resectr is labeled for resection of any intrauterine pathology/tissue, but is especially effective with endometrial polyps.
An operative hysteroscope, a source of suction, a source of distention media, tubing for inflow and outflow, and a tissue catch for pathology. To order the Resectr accessories, please go to www.precisionmedical.com/Minerva
The Resectr utilizes purely mechanical cutting.
Yes. The rotating collar that enables window rotation is located on the connection of the cannula to the handle. This allows for an easy and ergonomic case execution, reducing procedure time and physician fatigue.