Outpatient Procedures

When establishing MyoSure procedures in an outpatient/ambulatory setting, it is important to adhere to appropriate regulations and implement required protocols.

Required Equipment

To ensure that your outpatient setting is properly equipped to safely and effectively conduct tissue removal, we have provided a list of equipment and supplies that may be necessary to perform a MyoSure procedure. The following is a sample list of the key components you may need. It does not include prep tray or sterile pack components, additional optional tools and required safety equipment. Every physician should use his or her clinical expertise and judgment to decide which supplies are necessary for this procedure.

  • MyoSure tissue removal system controller*
  • MyoSure device
  • MyoSure hysteroscope
  • A fluid management system such as the Aquilex® system, or pressure cuff and a IV pole to hang the bag*
  • ≥1000 mL bag of saline
  • Cysto tubing
  • Buttocks drape
  • Enzymatic cleaner for the scope after the procedure
  • Sterile gown
  • Sterile gloves
  • Betadine Solution

*The MyoSure MANUAL device does not require fluid management capital equipment. Additionally, the MyoSure MANUAL device does not require the MyoSure controller unit.

IMPORTANT SAFETY INFORMATION

The MyoSure® tissue removal system, consisting of the MyoSure tissue removal devices (LITE, REACH, XL) and MyoSure controller, is intended for hysteroscopic intrauterine procedures by trained gynecologists to resect and remove tissue including submucous myomas, endometrial polyps, and retained products of conception. The MyoSure MANUAL hysteroscopic tissue removal device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception. MyoSure products are not appropriate for patients who are or may be pregnant, or are exhibiting pelvic infection, cervical malignancies, or previously diagnosed uterine cancer.

For more details on risks and benefits of the MyoSure system, MyoSure MANUAL tissue removal device, MyoSure hysteroscope and the Aquilex® fluid control system, please consult their respective IFUs.