When you discuss the Mara Water Vapor Ablation System with your patients, you can recommend it with confidence. An international, multicenter pivotal clinical study that enrolled 155 women, demonstrated that Mara significantly reduces heavy menstrual bleeding and improves quality of life. 79% of patients met the primary endpoint of the study with a PBLAC score of ≤ 75 at 1 year.1 Additionally 75% of US study participants were treated in the office setting.2 Common adverse events within the first 2 days may include uterine cramping, nausea, vomiting, vaginal discharge and infection. There were no serious device or procedure-related adverse events.1
achieved a PBLAC score of ≤ 751
had bleeding reduced by ≥50%2
Consistent positive results continued to be seen three years after their Mara treatment.1
^ Based on patient reported Menorrhagia Impact Questionnaire (MIQ) scores.
* Improvement reported 1 year after treatment for those women whose periods affected their sex life.
† Improvement reported 1 year after treatment for those women who experienced menstrual cramping.
Mara has been demonstrated in the pivotal clinical study to successfully treat women traditionally not indicated for endometrial ablation1:
2020
Johns DA, Garza-Leal JG. Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years after Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding. J Minim Invas Gynecol. Published Online Sept 2019.
2019
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.
Basinski, C. Post-ablation Cavity Evaluation: A Prospective, Multicenter, Observational Study to Assess Hysteroscopic Evaluation of the Uterine Cavity in Subjects Who Have Undergone Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding. (Plenary) J Minim Invasiv Gynecol 2019 Nov/Dec Vol. 26, Issue 7, Suppl S9.
Garza-Leal, J. There is No Correlation Between Long-Term Hysteroscopic Access to the Uterine Cavity and Menstrual Bleeding Status Following Use of Water Vapor Ablation to Treat Heavy Menstrual Bleeding. J Minim Invasiv Gynecol 2019 Nov/Dec Vol. 26, Issue 7, Suppl S29.
Levine, D. Long-Term Bleeding Status and Hysteroscopic Cavity Access Results Following Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding in Subjects Who Have Large Cavities, Uterine Myoma and/or Intratubal Contraceptive Inserts. J Minim Invasiv Gynecol 2019 Nov/Dec Vol. 26, Issue 7, Suppl S45.
2018
Levie MD, et al. Endometrial Ablation Using Water Vapor: 36-Month Follow-up. J Minim Invasiv Gynecol 2018 25 (7) Suppl S46.
2017
Levine, DJ. Endometrial Ablation Using Water Vapor: 24-month follow-up. J Minim Invasiv Gynecol 2017 Nov/Dec 24(7) Suppl S43.
van Eijndhoven H, van Baal M, Lenglet J, Thurkow A. Post Vapor Ablation Cavity Evaluation: A Pilot Study. J Minim Invasiv Gynecol 2017 Nov/Dec 24(7) Suppl S42-3.
2016
Johns DA, Harris M for the AEGEA Pivotal Investigators Group. The AEGEA Vapor System for Endometrial Ablation: Results from a Prospective, Multicenter Pivotal Clinical Trial. J Minim Invasiv Gynecol 2016 23(6) Suppl S192.
Brody, K. Endometrial Ablation with the AEGEA Vapor System in an Office Setting. J Minim Invasiv Gynecol 2016 23(6) Suppl S96.
Levine DJ. The AEGEA Vapor System and Endometrial Ablation: Results in Patient Subpopulations Treated in the Pivotal Clinical Trial Who Have Large Cavities, Uterine Myomata, Mullerian Anomalies and Intratubal Contraceptive Inserts. J Minim Invasiv Gynecol 2016 23(6) Suppl S96.
Coad J. et al. Occurrence of Hyperthermic Vasculopathy in Desiccating versus Non-desiccating Endometrial Ablation Failures: A Clinicopathologic Study. J Minim Invasiv Gynecol 2016 23(6) Suppl S114.
2015
Thurkow A, van Baal M, van Eijndhoven M. Final Results of a Multicenter Trial of Safety and Efficacy of the AEGEA Vapor System for the Treatment of Menorrhagia. J Minim Invasiv Gynecol 2015 22(6) Suppl p. S46.
Garza-Leal J, Hernandez I, Castillo L, Harris M. Endometrial Ablation with the AEGEA Vapor System in Challenging Uterine Anatomies. J Minim Invasiv Gynecol 2015 22(6) Suppl. P. S46.
2014
Thurkow A, van Baal M, van Eijndhoven M. Preliminary Results of a Multi-Center Trial of Safety and Efficacy of the AEGEA Vapor System for the Treatment of Menorrhagia. J Minim Invasiv Gynecol 2014 21(99) p. 147-8.
Garza-Leal J, Hernandez I, Castillo-Saenz L, Harris M. The AEGEA Vapor System: An In Vivo Peri-hysterectomy Study. J Minim Invasiv Gynecol 2014 21(99) p.140-1.
2010
Garza-Leal J, Hernandez I, Castillo L. Successful Vapor-Based Endometrial Ablation: In Vivo Peri-Hysterectomy Study. J Minim Invasiv Gynecol 2010 18(4) p. 445-8.
2009
Garza-Leal J, Hernandez I, Castillo L. AEGEA Vapor-Based Endometrial Ablation: Peri-hysterectomy Proof of Concept. J Minim Invasiv Gynecol 2009 16(99) p. 65
The Mara Water Vapor Ablation System is indicated 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.
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 contraindicated for those who have suspected uterine cancer, pre-malignant conditions of the endometrium, endometrial hyperplasia, prior classical cesarean section, transmural myomectomy (including myomectomy performed immediately prior to Mara procedure), taking medications that thin the uterine muscle, uterine length <6cm, prior endometrial ablation, active genital or urinary tract infection, PID, or systemic bacterial infection, IUD currently in place, suspected hydrosalpinx or undiagnosed abnormal vaginal bleeding. Mara is not a sterilization procedure. Rare but serious risks include, but are not limited to, perforation, infection, thermal injury, and serious complications in future pregnancies. Temporary side effects may include cramping, nausea, abdominal pain and distension, vomiting, vaginal infection, and endometritis. Inform patients to contact you if they experience a possible side effect related to Mara. For detailed benefit and risk information, please consult the IFU.