Minerva
Endometrial Ablation System

If heavy periods are making it difficult for you to live a normal life, Minerva may be the answer for you. The Minerva Treatment is a one-time, safe, effective, quick and complete procedure that can reduce heavy bleeding. The treatment can be done at your Minerva Specialists clinic, without making incisions or using general anesthesia that puts you to sleep.

Why Doctors Choose Minerva

The Minerva Treatment can be done at any time during the menstrual cycle. It is a 3 to 4 minute treatment that can be done in your doctor’s office, and you do not need to be put to sleep (general anesthesia). Clinical studies tested the Minerva System and the following benefits were found.

  • 92%of Women had their periods Reduced to a Normal or Less level (Treatment Success)1
  • 66%of Women had their bleeding Completely Eliminated (Amenorrhea)1
  • 81%of Women had their PMS Reduced (Pre-Menstrual Symptoms)1
  • Women have improved their desire or interest in sexual activities (if sexually active)8.
  • 99% of Patients would Recommend the Procedure to a friend or a relative1
  • Fast Procedure Time of just 3 to 4 Minutes.

One year following the Minerva Treatment in a clinical study conducted for FDA approval.

Why Should You Consider Minerva?

Not Based on a Head-to-Head Study. Data from “Intent-to-Treat” populations at 1 year follow-up from Clinical Trials results in the Summary of Safety and Effectiveness Data on file at www.FDA.gov for Minerva®, Her Option®, HTA® System, and NovaSure®.

  • Patient success was defined as a reduction in PBLAC menstrual diary score from ≥150 pre-treatment to ≤ 75 at 12 months post-procedure. Amenorrhea was defined as a score of 0.
  • Secondary study endpoints included the amenorrhea rate, length of procedure (Handpiece insertion to removal), and responses from a patient satisfaction questionnaire.

How Does the Minerva System Work?

The Minerva System works by treating the endometrium (tissue lining of the uterus) with heat. This tissue is the source of heavy bleeding in women who have not reached menopause. Minerva is only for women who do not want to have children in the future.

Here’s what you can expect

Before, During, and After the Minerva Treatment.

What Happens Before Treatment?

Before treatment, you will be taken to the treatment room. The nurse will take your blood pressure, temperature, and other important information. Nurses will likely tape a number of wires on your chest to keep track of how well your heart is working.

You will also be given some medication to help you with any pain and make you relax. An oxygen mask may also be placed on your face to help you breathe. Your doctor’s assistant will prepare you for the procedure by cleaning your vagina with a special solution that kills germs.

What Happens During Treatment?

At the time of the procedure, the doctor will insert a speculum (a medical tool that opens your vagina) so that your doctor can see inside. The doctor may make your cervix numb so that you do not feel pain during the procedure. Based on this procedure, the doctor may determine that you are not a candidate for treatment with Minerva. In that case, the doctor will talk to you about other options to treat your heavy menstrual bleeding.

The doctor will gently dilate (open) your cervix to insert the soft tip of the Minerva device into your uterus. The Minerva Controller will then provide energy to heat the inside of your uterus for 2 minutes. At the end of the treatment, the doctor will completely remove the device from your uterus. The entire treatment, from the time the device is inserted until the device is removed, usually takes less than 4 minutes.

What Happens After the Treatment?

After treatment, you will be taken to a recovery area where you will be watched for about 1 hour to make sure there are no complications. You may experience some mild to moderate low abdominal cramping and pain. The recovery room nurse may give you some medication for this. You will then be released to go home. It is important that someone is with you to take you home. You cannot drive immediately after the procedure because of the medication you were given.

Most patients experience some mild low abdominal pain for a day or so, which usually is treated with over the counter (non-prescription) pain medication that your doctor will recommend. Patients also reported vaginal discharge following the procedure. During the first few days, the discharge is likely to be bloody in color, but it will gradually turn clear. The total time of vaginal discharge varies, but is expected to last for two to four weeks, so it is recommended that you wear some sanitary protection (for example a panty liner) during this time.

When to Call Your Doctor?

Your doctor’s office will likely call you to check on you after your treatment. However, if after the procedure you are experiencing increasing pain, increased bleeding, greenish foul smelling vaginal discharge, or have a fever greater than 100.4°F, immediately call your doctor’s office. In rare cases, endometrial ablation can cause a serious injury that, if not treated promptly, can lead to death.

If you call your doctor at night or on a weekend, your doctor’s office will likely have an answering service that will put you in touch with your doctor or the doctor on-call. If you are not able to talk to your doctor, call 911 or go to the nearest Emergency Room.

when to call a doctor

How to Choose a Treatment with your Doctor?

The first step is to talk to your doctor about your heavy bleeding problem. Your doctor will do a series of tests to find the cause of your excessive menstrual bleeding. Excessive bleeding by itself is not a disease. It is a sign or symptom of a number of possible medical conditions.

Using ultrasound and/or hysteroscopy (methods used by doctors to look at the inside and outside of your uterus), and some other medical tests, your doctor will find the cause of your bleeding.

Your doctor will then help you select the right treatment. Depending on the reason for your excessive bleeding, your doctor may suggest that you first try medications. If medications do not work, or you are not allowed to take them for other reasons, your doctor may suggest endometrial ablation using the Minerva device.

The following table shows common treatments used for excessive bleeding and the advantages and disadvantages for each.

Treatment Options

The table below shows common treatment options along with their advantages and disadvantages.

It is very important for you to understand that treatment with the Minerva Endometrial Ablation Device should only be performed if you are absolutely sure that you do not want to have children in the future. This treatment cannot be undone or reversed. Becoming pregnant after this procedure is dangerous for both mother and unborn child. Your doctor will talk to you about ways to avoid pregnancy after surgery (birth control).

Who Should Not Have the Minerva Treatment?

The Minerva System should not be used in patients who have, or had, the following conditions:

  • Currently pregnant or wants to become pregnant in the future. PREGNANCY AFTER ABLATION CAN BE DANGEROUS FOR BOTH MOTHER AND UNBORN BABY.
  • Known or suspected cancer of the uterus.
  • Any weakness of the wall of the uterus. This may be due to past surgeries or long-term use of some medications. Talk to your doctor for more information.
  • Had an endometrial ablation in the past. Repeat ablation can cause serious injury.
  • Current infection, for example of the uterus, ovaries, bladder or other organs. This procedure should not be used if you have an infection. Any infection must heal before the ablation procedure can be scheduled.
  • Intrauterine device (IUD) in the uterus. Patient must agree to remove the IUD before the treatment.
  • Patients with Essure™. It is not known whether the Minerva Treatment is safe and effective in patients who have had the Essure™ device in place..
  • A patient with a very small uterus should not have the treatment because it may result in injury. Your doctor will measure your uterus to see if it is too short for the Minerva Treatment.
  • Your doctor will explain the full list of contraindications and how they may or may not affect your specific situation.

Risks & Considerations of the Minerva Treatment

With any surgery, there are risks related to the treatment and anesthesia used during the treatment. Your doctor will talk to you about the risks of the Minerva treatment and will give you details about your individual situation. It is important for you to know the risks of the Minerva Treatment.

Learn More

The Minerva Endometrial Ablation System was tested in two clinical studies, the Minerva Single-Arm Study with 110 patients (study complete) and the Minerva Randomized Study with 102 patients (study in progress). Please click HERE for an explanation of how the two studies were conducted.

A number of risks were seen during this testing of the Minerva System. These risks are listed in the following table and were reported within the first month following the Minerva Treatment. It is also important to know how often these risks may happen. In the table this information is shown using percent (%). The percent (%) shows how many patients had this event when 100 women were treated. For example, the 1% next to “fever” means that when 100 patients were treated, 1 patient experienced a fever. You can discuss these risks with your doctor for more information.

The risks listed in the table below were reported within the first year following the Minerva Treatment in the 212 women evaluated in the two clinical studies.

Adverse Event/Symptom Minerva Single-Arm Study

Minerva Randomized Study

Minerva  (n=110)

Minerva (n=102)

Rollerball (n=51)

Intra-operative Adverse Events and Symptoms
Skin Rash and/or Itching or Burning Sensation

0 (0.0%)**

1 (1.0%)

0 (0.0%)

Post-operative Adverse Events and Symptoms (Recovery room to < 24 hours) ***
Pelvic Cramping

64 (58.2%)

51 (50.0%)

23 (45.1%)

Vaginal Discharge and/or Unpleasant Vaginal Smell or Burning or Other Abnormal Sensation

15 (13.6%)

32 (31.4%)

16 (31.4%)

Bleeding or Spotting

8 (7.3%)

39 (38.2%)

15 (29.4%)

Nausea and/or Vomiting

17 (15.5%)

17 (16.7%)

8 (15.7%)

Weakness, Fatigue, Sleepiness, Lack of Concentration, Dizziness

6 (5.5%)

5 (4.9%)

1 (2.0%)

Abdominal Pain and/or Bloating

10 (9.1%)

0 (0.0%)

0 (0.0%)

Circulatory Symptoms

4 (3.6%)

5 (4.9%)

3 (5.9%)

Headache

4 (3.6%)

0 (0.0%)

2 (3.9%)

Backache

3 (2.7%)

1 (1.0%)

0 (0.0%)

Fever

0 (0.0%)

1 (1.0%)

0 (0.0%)

Agitation

0 (0.0%)

1 (1.0%)

2 (3.9%)

Vulvar Pruritus

0 (0.0%)

1 (1.0%)

0 (0.0%)

Urinary Disturbance

0 (0.0%)

1 (1.0%)

1 (2.0%)

Post-operative Adverse Events and Symptoms (≥ 24 hours – 2 Weeks) ***
Pelvic Cramping

12 (10.9%)

0 (0.0%)

0 (0.0%)

Abdominal Pain and/or Bloating

1 (0.9%)

3 (2.9%)

1 (2.0%)

Pelvic Pain

0 (0.0%)

1 (1.0%)

0 (0.0%)

Nausea and/or Vomiting

1 (0.9%)

0 (0.0%)

0 (0.0%)

Vaginal Discharge and/or Unpleasant Vaginal Smell or Burning or Other Abnormal Sensation

0 (0.0%)

1 (1.0%)

0 (0.0%)

Weakness, Fatigue, Sleepiness, Lack of Concentration, Dizziness

0 (0.0%)

1 (1.0%)

1 (2.0%)

Circulatory Symptoms

1 (0.9%)

0 (0.0%)

0 (0.0%)

Constipation

1 (0.9%)

0 (0.0%)

1 (2.0%)

Pelvic Inflammatory Disease

1 (0.9%)

0 (0.0%)

0 (0.0%)

Fever

1 (0.9%)

0 (0.0%)

0 (0.0%)

Endometritis or Endomyometritis

0 (0.0%)

1 (1.0%)

2 (3.9%)

Skin Rash and/or Itching or Burning Sensation

0 (0.0%)

1 (1.0%)

1 (2.0%)

Post-operative Adverse Events and Symptoms (>2 Weeks – 1 Year)
Pelvic Inflammatory Disease

0 (0.0%)

1 (1.0%)

0 (0.0%)

Hematometra

0 (0.0%)

1 (1.0%)

0 (0.0%)

Dysmenorrhea

0 (0.0%)

0 (0.0%)

1 (2.0%)

Long-Term Follow-up Adverse Events and Symptoms

(>1 Year – 3 Years)
(n=101)

>1 Year

Pelvic Cramping

2 (2.0%)

* Possibly, probably, or highly probably related to Device or Procedur** Percent of patients who reported specific endometrial ablation-related adverse events and symptom*** Ten patients in the Single-Arm Study and two patients in the RCT reported the same AE at the < 24 hours and the 24 hours – 2 Weeks visits † Gynecologic Adverse Events during Long-Term Follow-up (2 and 3 years after the procedure)

Additional Risk-Related Information

The Minerva Treatment is a surgical procedure. As with all surgeries, serious injury or death can occur. The following are also possible risks during or after endometrial ablation treatment.

  1. Injury (e.g., tear) of the uterus.
  2. Injury to organs in the abdomen (e.g., bowel or bladder).
  3. Potential complication (e.g., new pain during menstrual cycles) in women who have previously had a tubal ligation.
  4. Serious pregnancy complications for both mother and unborn baby. The Minerva Treatment does not protect women from future pregnancy. Patients will still need to use contraception or undergo a permanent sterilization procedure.
  5. Life-threatening infection. Patients should contact their doctor if they develop any of the following:
    • Fever higher than 100.4 °F
    • Abdominal pain that becomes worse and does not get better by pain medication given by the doctor or by ibuprofen
    • Nausea
    • Vomiting
    • Bowel or bladder problems
    • Vaginal discharge that has a foul smell.
  6. Other risks and complications leading to serious injury or death. Undergoing an endometrial ablation procedure may make it more difficult to diagnose endometrial cancer in the future.

What Were the Results?

Minerva Endometrial Ablation System was evaluated in two clinical studies, the Minerva Single-Arm Study and the Minerva Randomized Clinical Trial. These clinical studies were conducted at seventeen medical hospitals in the United States, Canada, Mexico, and Hungary.

Click here for complete information about the Clinical Study

Doctors who conducted these clinical studies were gynecologists and treated women with heavy bleeding. The women treated with the Minerva System were from 25 to 50 years old, had heavy monthly bleeding, and did not want to have more children. All of the women were examined to see if there was a cause of their excessive menstrual bleeding and to make sure they were healthy.

The Minerva Single-Arm Study was conducted by seven doctors at different hospitals and clinics. There were 110 women included in this study. The women kept a record of their bleeding using special diary charts. They filled out the diaries for their periods before the Minerva Treatment and then completed one diary for each monthly period after the Minerva Treatment. Each diary was collected to determine the amount of bleeding before and after the Minerva Treatment. In order to be in the clinical study, the patient’s bleeding level had to be more than a certain amount. The Minerva Treatment was considered successful if a patient had a bleeding level that was normal or below normal at 12 months following the Minerva Treatment..

The women had follow-up visits with their doctor at 3 months, 6 months, and 1 year following the Minerva procedure. During these visits, the doctor examined the patients and collected their diaries to check their monthly bleeding level. The doctor also made sure all women were using birth control.

The second clinical study, the Minerva Randomized Clinical Trial, is currently in progress and involves 153 patients at 13 hospitals and clinics in three countries, including the United States. In this study, the Minerva Endometrial Ablation System is being compared to another treatment for abnormal uterine bleeding called Rollerball ablation.

In a Randomized  Clinical Trial, a computer randomly assigns the patients to one of two treatment groups, either the Minerva Endometrial Ablation group or Rollerball Ablation group. A total of 153 patients are involved in this study, 102 of them were treated with the Minerva Endometrial Ablation System and 51 were treated with the Rollerball Ablation. Unlike the Minerva Single Arm Study in which women used diaries to measure bleeding levels, this study measured the patient’s bleeding before and after the treatment by collecting and testing the patient’s used sanitary products (tampons and pads). The used sanitary products were sent to a laboratory to measure the amount of blood. The reported patient risks for this ongoing study are available through the 30-day period following treatment and are shown in the “Risks of the Minerva Treatment” section..