References

  1. The American College of Obstetricians and Gynecologists. FAQ June 2016.  https://www.acog.org/Patients/FAQs/Heavy-Menstrual-Bleeding?IsMobileSet=false https://www.cdc.gov/ncbddd/blooddisorders/women/menorrhagia.html.
  2. SE-3000 Pivotal Trial Patient Questionnaire, AEGEA Medical.  Data on file.
  3. Mara Water Vapor Ablation System Instructions For Use.
  4. Levie MD, Chudnoff SG. A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System. J Minim Invas Gynecol. May/June 2019; 26(4); 679-87.
  5. Levie H, et al. Endometrial Ablation Using Water Vapor: 36-Month Follow-up. J Minim Invasiv Gynecol 2018 25 (7) Suppl S46.

All references on file at AEGEA Medical, Inc


Important Safety Information:

The Mara Water Vapor Ablation System is indicated to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. Pregnancy following the Mara procedure can be dangerous. The Mara procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. As with all surgical procedures, there are risks and considerations associated with the use of the Mara Water Vapor Ablation System. Please refer to the device labeling for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications.