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.
Clinically proven
safe and effective.
When you discuss the Mara™ Water Vapor Ablation
System with your patients, you can recommend it
with confidence. An international, multi-center
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.3
Additionally, 73% of the U.S. patients in the pivotal
trial were treated directly in the office setting.3 There were
no serious device or procedure-related adverse events.
Long-Term Results
Women Reporting No Bleeding to Moderate Bleeding3
(Through 3 Years)
^Based on PACE clinical study. 90% statistic also includes visualization of the ostia and minimal findings of severe adhesions a mean of 4 years post treatment.
High Quality of Life Improvement3
* 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.
Treats More Uterine Anatomies
Mara has been demonstrated in the pivotal clinical study to successfully treat women traditionally
not indicated for endometrial ablation3:
- Long cavities up to 12 cm
- Any uterine width (no measurement needed)
- Cavities with submucosal (type 2), intramural (types 3 and 4)
and/or subserosal (types 5 and 6) myomas up to 4 cm - History of low-transverse c-section
- In the presence of Essure®
Publications and Abstracts
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 Dessicating versus Non-dessicating 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 Multi-Center 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 Min Invasiv Gynecol 2009 16(99) p. 65
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.