Safety Information

Minerva ES® Endometrial Ablation System

Prescriptive Information

Refer to the device directions for use for complete instructions on the device.

Indications

The Minerva ES® Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

Contraindications

The Minerva ES Endometrial Ablation System is contraindicated for use in:

  • patient who is pregnant or who wants to become pregnant in the future.

Pregnancies following ablation can be dangerous for both mother and fetus.

  • patient with known or suspected uterine cancer or pre-malignant conditions of the endometrium, such as unresolved adenomatous hyperplasia.
  • patient with any anatomic condition (e.g., history of previous classical cesarean section or transmural myomectomy, including hysteroscopic and/or laparoscopic myomectomy performed immediately prior to the Minerva ES procedure) or pathologic condition (e.g., requiring long-term medical therapy) that could lead to weakening of the myometrium.
  • patient with a history of endometrial ablation and/or resection (including endometrial ablation/resection performed immediately prior to Minerva ES procedure) regardless of the modality by which it was performed.

REPEAT ABLATION MAY RESULT IN SERIOUS PATIENT INJURY.

  • patient with active genital or urinary tract infection at the time of the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis or cystitis).
  • patient with an intrauterine device (IUD) currently in place and which is not removed prior to the Minerva ES procedure.
  • patient with a uterine cavity length less than 4 cm. The minimum Plasma Formation Array length is 4 cm. Treatment of a uterine cavity with a length less than 4 cm may result in thermal injury to the endocervical canal.
  • patient with a narrow uterine cavity.
  • patient where the Array Opening Indicator is in the Red Zone following deployment of the Minerva ES Disposable Handpiece.
  • patient with active pelvic inflammatory disease.
  • patient with undiagnosed vaginal bleeding.

Warnings

Uterine Perforation Warnings

  • Use caution not to perforate the uterine wall when sounding, dilating or inserting the Minerva ES Disposable Handpiece.
  • Activation of the Minerva ES Disposable Handpiece in the setting of a uterine perforation is likely to result in serious patient injury.
  • The risk of uterine perforation is increased in patients with abnormal or obstructed uterine cavities including obstruction by fibroids that distort the uterine cavity.
  • It has been reported in the literature that patients with a severely anteverted, retroflexed or laterally displaced uterus are at greater risk of uterine wall perforation during any intrauterine manipulation.
  • If the Minerva ES Disposable Handpiece is difficult to insert into the cervical canal, use clinical judgment to determine whether or not further dilation is required. Forcibly advancing the Minerva ES Disposable Handpiece against resistance is likely to increase the risk of perforation or creation of a false passage. Sufficient dilation is required for safe insertion.
  • To prevent injury to the endocervical canal, ensure the Plasma Formation Array is unlocked before removing the Minerva ES Disposable Handpiece from the uterus.
  • Excessive force applied during placement of the Minerva ES Disposable Handpiece may result in tissue injury including perforation.
  • Use caution during placement of the Minerva ES Disposable Handpiece in severe uterine angulations to prevent perforation.
  • The Minerva ES System performs an integrity test to evaluate the integrity of the Minerva ES Disposable Handpiece and indirectly assess the integrity of the uterine cavity (Uterine Integrity Test) and sounds an alarm warning prior to treatment if the test fails.
  • If the UTERINE integrity TEST fails after reasonable attempts to implement the troubleshooting procedures, abort the procedure.
  • Although designed to detect a perforation of the uterine wall, this test is an indicator only and it might not detect all perforations. Clinical judgment must always be used.
  • If a uterine perforation is suspected and/or confirmed, the procedure should be terminated immediately.
  • For patients in whom the procedure was aborted due to a suspected uterine wall perforation, a work-up for perforation should be considered prior to discharge.
  • Post-treatment, any patient-reporting signs/symptoms that could indicate a serious complication, e.g., bowel injury, should be thoroughly evaluated without delay.

General Warnings

  • Endometrial ablation using the Minerva ES System is not a sterilization procedure. Therefore, the patient should be advised of appropriate birth control methods.
  • Endometrial ablation is intended for use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following the procedure. Pregnancy following ablation may be dangerous for both mother and fetus.
  • Endometrial ablation does not eliminate the potential for endometrial hyperplasia or cancer of the endometrium and may mask the physician’s ability to detect or make a diagnosis of such pathology.
  • Patients who undergo endometrial ablation procedures who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy. This can occur as late as 10 years post procedure.
  • The Minerva ES procedure should not be performed concomitantly with placement of the Essure device.
  • The safety and effectiveness of the Minerva ES System has not been evaluated in patients with the Essure device.

Technical Warnings

  • The Minerva ES Disposable Handpiece is supplied sterile. Do not use the sterile single-patient use Minerva ES Disposable Handpiece if the packaging appears to be damaged or there is evidence of tampering.
  • For single-use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the Minerva ES Disposable Handpiece and/or lead to failure of the Minerva ES Disposable Handpiece which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the Handpiece and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the Handpiece may lead to injury, illness or death of the patient.
  • The used Minerva ES Disposable Handpiece must be treated as biohazardous waste and disposed of in accordance with hospital or clinic standard practice where the treatment is performed.
  • If any hysteroscopy procedure is performed with hypotonic solution immediately prior to Minerva ES procedure, then the uterine cavity must be flushed with normal saline prior to treatment with the Minerva ES System. The presence of hypotonic fluid may reduce the efficiency of the Minerva ES System.
  • Plugging the Minerva ES Disposable Handpiece into the Minerva ES RF Controller starts the pre-insertion Handpiece integrity check. CO2 is delivered to the Minerva ES Disposable Handpiece to verify patency. This test takes approximately 10 seconds to complete and must be performed with the MINERVA ES Disposable Handpiece external to the patient to eliminate the risk of air or gas embolism as well as any false readings. The Minerva ES RF Controller touch screen will display the progress of the test. After the test image disappears, it is safe to insert the Minerva ES Disposable Handpiece.
  • The Minerva ES Endometrial Ablation System may interfere with normal functions of some types of implanted pacemakers or implanted cardioverters/defibrillators. The Minerva ES System should not be used with patients who have pacemakers or other electrical implants. Check if the patient has pacemaker or implanted cardioverter/defibrillator prior to use. Consult the cardio-rhythm device manufacturer for information about the effects of RF energy on these devices.
  • Care should be taken to ensure the patient does not contact metal parts which are earthed or which have an appreciable capacitance to earth, such as direct contact with the metal on tables.
  • Danger: explosion hazard. Do not use in the presence of a flammable anesthetic mixture. Do not use in the presence of flammable gases or liquids.
  • Failure of the Minerva ES RF Controller could result in an unintended increase in output power.
  • Do not use the Minerva ES System near or in a magnetic resonance (MR) environment.

Precautions

  • A false passage can occur during any procedure in which the uterus is instrumented, especially in cases of a severe anteverted retroflexed or a laterally displaced uterus. Use caution to ensure that the Minerva ES Disposable Handpiece is properly positioned in the uterine cavity.
  • Patients who have undergone endometrial ablation and are later placed on hormone replacement therapy should have a progestin included in their medication regimen in order to avoid the increased risk of endometrial adenocarcinoma associated with unopposed estrogen replacement therapy.
  • The safety and effectiveness of the Minerva ES System has not been fully evaluated in patients:
    • with a uterine sound measurement greater than 10 cm;
    • with submucosal fibroids that distort the uterine cavity;
    • with bicornuate, septate or sub-septate uteri;
    • with medical (e.g., GnRH agonist) or surgical pretreatment; or
    • who have undergone a previous endometrial ablation including the Minerva ES endometrial ablation procedure.
  • The Minerva ES System consists of the following components:
    • Single-patient use Minerva ES Disposable Handpiece with connecting cord and desiccant
    • Minerva ES RF Controller with footswitch and power cord
    • Minerva ES CO2 canister
    • Minerva ES argon canister
  • To ensure proper operation, never use other components with the Minerva ES System. Inspect the components regularly for damage, and do not use them if damage is apparent. The use of any cables or accessories other than those specified in these instructions may result in increased emissions or decreased immunity of the Minerva ES RF Controller.
  • The Minerva ES Disposable Handpiece should only be used by physicians trained in the use of the Minerva ES Disposable Handpiece.
  • The Minerva ES Disposable Handpiece must be used only in conjunction with the Minerva ES RF Controller. No other handpieces can be used with the Minerva ES RF Controller.
  • Patients must be informed of the risks and possible adverse events associated with the endometrial ablation procedure and use of the Minerva ES Endometrial Ablation System.
  • The user should inspect the Minerva ES Disposable Handpiece for damage prior to use.
  • The Minerva ES Desiccant is non-sterile, and the packaging should not be placed in the sterile field.
  • Do not use the Minerva ES Desiccant if desiccant material is pink in color.
  • The Minerva ES Disposable Handpiece must be external to (outside of) the patient before plugging the connecting cord into the appropriate port on the front panel of the Minerva ES RF Controller.
  • Do not use the Minerva ES Endometrial Ablation System in presence of volatile solvents or flammable anesthetics.
  • In the event of a Minerva ES RF Controller failure, disconnect the Minerva ES Disposable Handpiece, use the ON/OFF Switch, or unplug the power cord to stop Argon and CO2 flow, and RF energy delivery.
  • Do not operate unit in a moist environment, as a shock hazard may exist. If liquids have entered the unit, the Minerva ES RF Controller must be returned to the manufacturer for testing prior to use.
  • Interference produced by the operation of high-frequency equipment, such as the Minerva ES RF Controller, may adversely affect the operation of other electronic medical equipment such as monitors and imaging systems. If electromagnetic interference with other equipment is suspected, reorient the Minerva ES Disposable Handpiece or remove possible sources of interference (e.g., cellular phones, radios, etc.) from the room.
  • It is recommended that any monitoring equipment or leads be placed as far as possible from the Plasma Formation Array when high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient. Needle monitoring electrodes are not recommended. Monitoring systems incorporating high frequency current-limiting devices are recommended for use.
  • Do not use the Minerva ES Disposable Handpiece if wires are exposed as this increases the risk of an electrical shock or fire.
  • Failure of the Minerva ES Endometrial Ablation System equipment could result in an unintended increase of output power.
  • Use of accessories and cables, other than those specified for the Minerva ES Endometrial Ablation System, may result in increased emissions or decreased immunity of the system.
  • Use only the hospital grade power cord and Minerva ES Footswitch supplied with the Minerva ES RF Controller.
  • Removing screws and opening of the Minerva ES RF Controller will invalidate the warranty.
  • The Minerva ES RF Controller contains no user serviceable parts. Return to manufacturer for repairs.
  • Do not restrict the openings on the Minerva ES RF Controller enclosure, as they provide the required airflow for cooling.
  • The patient should not come into contact with earthed metal parts or parts with appreciable capacitance to earth. The use of antistatic sheeting is recommended.
  • Position the Minerva ES Disposable Handpiece connecting cord such that contact with patient or other electrical leads is avoided.
  • Position the Minerva ES RF Controller on a flat surface for clinical use.
  • Care should be taken not to damage the silicone membrane of the Plasma Formation Array during preparation and use.
  • Careful measuring of the uterus is important for safe and proper Minerva ES Disposable Handpiece PFA length setting to prevent thermal injury to the endocervical canal.
  • If during the ablation cycle the cervical balloon does not adequately seal the cervical canal, unintended thermal damage to the endocervical canal may occur as a result of hot fluid leaking from the uterine cavity into the canal. Use clinical judgment to continue with the ablation procedure if such a leak is suspected.
  • During the ablation cycle, ensure the connection tubing is not kinked or twisted which could reduce the flow of argon gas and reduce the effect of ablation.
  • During ablation, do not unlock the Minerva ES Disposable Handpiece handle or retract or remove the Minerva ES Disposable Handpiece.
  • The Minerva ES RF Controller is for use without a neutral electrode.
  • Use non-flammable agents for cleaning and disinfecting wherever possible.
  • Flammable agents used for cleaning, disinfecting, or as solvents of adhesives should be allowed to evaporate before application of RF energy.
  • Flammable solutions can pool under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. Fluids pooled in the body depressions and cavities should be evacuated before the Minerva ES RF Controller is used.
  • Endogenous gases (e.g., cotton and gauze saturated with oxygen) may be ignited by sparks produced during normal use of the Minerva ES RF Controller.
  • Do not position the Minerva ES RF Controller such that it is difficult to connect/disconnect the Minerva ES Disposable Handpiece connector.
  • To avoid risk of electric shock, the Minerva ES RF Controller must only be connected to a mains supply with protective earth.
  • Do not modify the Minerva ES RF Controller without authorization from Minerva Surgical.
  • The Minerva ES RF Controller needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the operators manual.
  • The use of Portable and Mobile RF Communications Equipment can affect the Minerva ES RF Controller.
  • The Minerva ES RF Controller should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Minerva ES RF Controller should be observed to verify normal operation in the configuration in which it will be used.
  • The power cord connection to the Minerva ES RF Controller provides a means of isolation. The Minerva ES RF Controller should be positioned so as to provide easy access to the power cord connection in the event that the unit must be quickly unplugged.

Potential Adverse Events

The most common side effects of endometrial ablation occur during or immediately following the procedure and include uterine cramping, vaginal discharge, bleeding or spotting, nausea and/or vomiting, fatigue, abdominal pain.

As with all endometrial ablation procedures, serious injury or death can occur.

The following adverse events could occur or have been reported in association with the use of other endometrial ablation systems and may occur when the Minerva ES Endometrial Ablation System is used:

  • Post-ablation tubal sterilization syndrome
  • Pregnancy-related complications
    NOTE: Pregnancy following endometrial ablation is very dangerous for both the mother and the fetus.
  • Thermal injury to adjacent tissue, including bowel, bladder, cervix, vagina, vulva and/or perineum
  • Perforation of the uterine wall
  • Hemorrhage
  • Hematometra
  • Difficulty with defecation or micturition
  • Uterine necrosis
  • Air or gas embolism
  • Infection or sepsis

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. The physician using the system must be trained in diagnostic hysteroscopy. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

All trademarks are the property of their respective owners.

L0172 Rev. A

Genesys HTA® System

Prescriptive Information

Refer to the device directions for use for complete instructions on the device.

Indications

Indications The Genesys HTA® System is a hysteroscopic thermal ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

Contraindications

The system is contraindicated for use in a patient:

  • who is pregnant or wants to be pregnant in the future, as pregnancy after ablation can be dangerous to both mother and fetus;
  • who has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia;
  • who has active pelvic inflammatory disease or pyosalpinx;
  • who has hydrosalpinx;
  • in whom a tight cervical seal cannot be established and maintained around the procedure sheath;
  • who has any anatomical condition (e.g., history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g., long term medical therapy) that could lead to weakening of the myometrium;
  • who has an intrauterine device in place; or
  • who has an active genital or urinary tract infection (e.g., cervicitis, endometritis, vaginitis, cystitis, etc.), at the time of treatment.

Warnings

General Warnings

  • Although endometrial ablation with the Genesys HTA System significantly decreases the likelihood of pregnancy, it is not a sterilization procedure. The patient should be advised of appropriate birth control methods.
  • Endometrial ablation does not eliminate the potential for endometrial hyperplasia or adenocarcinoma of the endometrium and may mask the physician’s ability to detect or make a diagnosis of such pathology.
  • Patients who undergo endometrial ablation procedures who have previously undergone tubal ligation may be at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy. This can occur as late as 10 years post-procedure.
  • DO NOT perform same day HTA procedure and hysteroscopic tubal occlusion/sterilization. Ablation may cause intrauterine synechiae which can compromise (i.e. prevent) the 3-month confirmation test (HSG) for the tubal occlusion device. Women who have inadequate 3month confirmation tests cannot rely on the tubal occlusion device for contraception.
  • Bench and clinical studies have been conducted which demonstrate that the HTA procedure can be safely and effectively performed with nickel titanium tubal micro-inserts in place. However, the HTA procedure should only be performed after the 3-month tubal occlusion confirmation test.

Technical Warnings

  • The Genesys HTA ProCerva ® Procedure Set is provided sterile and is intended for single use only. Do not attempt to resterilize or reuse any component of the procedure set.
  • Scope adapters should be reprocessed in accordance with the validated cleaning and sterilization procedure provided in the operator’s manual, Procedure Sheath Accessories – Sterilization and Assembly. Do not reuse any scope adapter that has not been cleaned and sterilized accordingly.
  • Do not use excessive force when attaching the procedure sheath to the scope adapter as such force may damage device components. Thermal injuries to patients have been reported in association with cracked or damaged procedure sheaths/adapters.
  • Care must be taken with advancement and movement of the procedure sheath to avoid uterine perforation.
  • The physician must maintain control of the procedure sheath (i.e., not hand off to another individual) for the duration of the treatment to avoid compromising the cervical seal. A compromise of the cervical seal could result in fluid leakage through the cervix, which could result in thermal injury to surrounding tissue.
  • Once heating has begun maintain a stable sheath position and do not remove the procedure sheath until the post-treatment cooling cycle has been completed as confirmed by the display screen, as heated fluid may cause thermal injury to the patient.
  • If system cooling is not possible (i.e., power loss), do not remove the procedure sheath from the patient until fluid in the uterus has cooled. It may take up to 10 minutes to ensure that fluid temperature in the uterus is below 45 °C. Exercise care when handling the procedure set, because the fluid may still be hot.
  • Excessive menstrual clotting at the time of treatment may cause the Genesys HTA ProCerva Procedure Set to become clogged. This condition may trigger an alert. If the condition cannot be resolved, the procedure should be discontinued. To avoid clogging the fluid lines with blood clots, the procedure should not be scheduled during menses. Also, consideration should be given to pretreatment with drugs such as GnRH agonists prior to performing the endometrial ablation to help induce a hypoestrogenic state.
  • Do not place the procedure sheath tubing over the patient’s leg or in contact with any part of the user’s or patient’s anatomy, as the tubing carries hot fluid and contact could result in thermal injury. The temperature of the tubing could be up to 55 °C.
  • Ensure that the temperature of the fluid in the cassette is below 45 °C prior to disconnection of the Genesys HTA ProCerva Procedure Set.
  • Do not look directly into the control unit’s laser aiming beam. Light from the LED may cause retinal damage.
  • Do not over-dilate the cervix.

Cautions

  • Endometrial ablation procedures using the Genesys HTA System should be performed only by physicians trained in diagnostic hysteroscopy procedures. Follow all Genesys HTA System instructions to reduce the possibility of compromised safety, malfunction, and/or injury to the patient and/or the user.
  • To avoid the risk of electric shock, ensure that the selected electrical supply outlet has a proper ground connection and complies with the information listed on the label located on the rear of the control unit.
  • To reduce the risk of explosion, do not operate the Genesys HTA System in the presence of flammable anesthetics or a flammable gas mixture with air, oxygen, or nitrous oxide.
  • Never use the Genesys HTA System with equipment that has not been safety tested for excessive leakage current.
  • Exercise care when handling liquids around electrical equipment. Do not attempt to operate the Genesys HTA System if liquid has spilled onto the unit.
  • The Genesys HTA System must be used only with the procedure sheath provided in the Genesys HTA ProCerva Procedure Set. Use of any other hysteroscopic procedure sheath sets will lead to compromised safety for the patient and user.
  • Do not hang more than three liters of saline from the hook on the IV pole.
  • Confirm that the vaginal speculum is an adequate size (width and length) to assure full separation of vaginal and vulvar tissue away from the procedure sheath, to avoid inadvertent thermal injury, and to provide visibility of the cervix. The temperature of the sheath at this location could be up to 65°C.
  • Do not rest the procedure sheath on the vaginal speculum during the procedure.
  • Leave the vaginal speculum in place throughout the procedure.
  • Confirm that the height of the control unit handle is properly adjusted to the height of the patient’s uterus to allow proper fluid flow and pressure, during the procedure. The laser aiming beam can be used as a secondary means to assist with proper height adjustment.
  • Ensure that the height of the control unit handle is no higher than the height of the patient’s uterus or fluid leakage into the peritoneal cavity and vagina may occur during the procedure.
  • Do not grasp the procedure sheath with the tenaculum as doing so may damage the procedure sheath which could result in thermal injury.
  • Throughout the procedure, carefully observe the junction of the procedure sheath with the external cervical os to confirm a tight cervical seal and that there is no fluid leakage.
  • Be Aware: The fluid loss alarm signals a loss of at least 10mL of fluid. Fluid losses in excess of 10 mL may occur in cases when the alarm is triggered.
  • Use caution when handling the fluid in the drainage bag after treatment, as the fluid at this stage may still be hot.
  • Follow hospital procedures for handling contaminated fluids and disposables.
  • Do not attempt to repair or alter any components/parts of the Genesys HTA System. All repairs and servicing are to be performed only by authorized Boston Scientific service personnel. See Section 8, Service and Warranty.
  • Patients who have undergone endometrial ablation, who are later placed on hormone replacement therapy, should have a progestin included in their regimen in order to avoid the increased risk of endometrial adenocarcinoma associated with unopposed estrogen replacement therapy irrespective of whether total amenorrhea has been achieved after ablation.
  • Use caution when performing the Genesys HTA System procedure on patients with nickel sensitivity, as the Genesys HTA ProCerva Procedure Set contains nickel.

The safety and effectiveness of the Genesys HTA System has not been evaluated in patients:

  • with a large uterine cavity (> 10.5 cm);
  • with a small uterine cavity (< 6.0 cm);
  • with submucous myomas and/or polyps;
  • with intramural fibroids > 4 cm, as documented on ultrasonogram, thought to be contributing to menorrhagia, such as those which distort the uterine cavity;
  • with bicornuate or full septate uterus;
  • undergoing repeat endometrial ablation procedures (e.g., resection, ablation); or
  • who are post-menopausal.

Potential Adverse Events

The most common side effects of endometrial ablation occur during or immediately following the procedure and include uterine cramping, nausea, vomiting, abdominal pain, urinary tract infection (UTI), Laceration, Endometritis, thermal injury to extremity, vaginal infection, cervical laceration, and Hematoma.

As with all endometrial ablation procedures, serious injury or death can occur. The following adverse events could occur or have been reported in association with the use of the first generation HTA System:

  • thermal injury to adjacent tissue, including cervix, vagina, vulva and/or perineum;
  • heated saline escaping from the system into the vascular spaces;
  • hemorrhage;
  • perforation of uterus;
  • complications with pregnancy (Note: Pregnancy following any endometrial ablation procedure is dangerous to both the mother and the fetus.);
  • risks associated with hysteroscopy;
  • post ablation tubal sterilization syndrome;
  • infection or sepsis; and
  • complications leading to serious injury or death.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. The physician using the system must be trained in diagnostic hysteroscopy. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

All trademarks are the property of their respective owners.

L0173 Rev. A