Frequently Asked Questions

Minerva ES

Why is the Minerva ES ablation cycle always 120 seconds?

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.

Does Minerva ES require direct tissue contact?

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.

How does the device respond to changes in the uterine cavity?

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.

What is Plasma?

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.

To what diameter is the cervix dilated?

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.

What do I do if I get an error code?

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.

How many times can I inflate the Cervical Sealing Balloon?

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.

What is the Amenorrhea Rate?

In a controlled clinical study conducted for a FDA approval, Minerva ES achieves an Amenorrhea rate of 72%, or 7 out of 10 women.

What is the rate of hysterectomy post-treatment?

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.

Do you have to do a hysteroscopy with Minerva ES?

According to the FDA, hysteroscopy is optional when performing endometrial ablation.

How many cases do you get per CO<sub>2</sub> Canister and Argon Canister?

The argon cartridge will last for approximately 7 treatments. A CO<sub>2</sub> cartridge will last for approximately 25 treatments.

Can I use Minerva ES after resecting a fibroid?

<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.

Can I use Minerva ES with Essure coils?

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.

Symphion

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.

Does Symphion utilize a mechanical blade?

Symphion utilizes RF plasma cutting / coagulation technology for fast tissue resection without dull blades that are often seen in older cutting technologies.

Does Symphion have an automatic fluid deficit readout?

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.

How do you calculate fluid deficit after a Symphion case?

Total Fluid Loss equals 2500mL minus Amount of saline remaining in 3000mL bag (approximately 500mL remain in the system)

Does the resection device dull or weaken during a long fibroid case?

No. Symphion uses bladeless RF plasma resection technology. As a result the device does not dull or weaken during treatment.

Do you need to run the resection device to aspirate?

Symphion has an independent aspiration mode.

What is the depth of tissue destruction beyond the diameter of the Symphion RD, when cutting?

Histologic evaluation of the tissue chips indicates a consistent depth of tissue thermal effect limited to ~ 80 microns.

Are additional canisters and tubing needed?

No. The Symphion Fluid Management Accessory (FMA) is all-inclusive.

Genesys HTA

What size hysteroscope can be used with Genesys HTA?

3.0mm diameter or smaller diagnostic hysteroscope can be used with the corresponding adapter.

Does HTA require an adapter?

Yes. To order, contact Minerva Customers Service at 855-646-7874.

What is the operating pressure of Genesys HTA?

Genesys HTA operates between 50-60mmHg of pressure.

How hot does the saline get during Genesys HTA ablation?

Target temperature is 90 degrees Celsius and will fluctuate several degrees during the treatment cycle

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

What sizes are available for Resectr?

Resectr comes in two sizes:
5Fr outer diameter, 5mm cutting window, 35cm length
9Fr outer diameter, 7.5mm cutting window, 35cm length

Can I use Resectr with any hysteroscope?

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.

Does the Resectr require the use of capital equipment?

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.

Can I use the Resectr on fibroids?

The Resectr is labeled for resection of any intrauterine pathology/tissue, but is especially effective with endometrial polyps.

What additional equipment do I need to use the Resectr?

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

Does the Resectr utilize mechanical or bipolar cutting?

The Resectr utilizes purely mechanical cutting.

Can I rotate the cutting window without rotating the handle?

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.