Sam Brusco, Associate Editor02.02.21
CooperSurgical acquired California-based, AEGEA Medical and its FDA-approved Mara Water Vapor Ablation System. The Mara endometrial ablation treatment uses water vapor to safely treat heavy menstrual bleeding in the doctor’s office. It is a two-minute, in-office treatment that ablates the lining of the uterus, the source of heavy menstrual bleeding in women who haven’t reached menopause.
About one-third of women seek treatment for heavy menstrual bleeding (also known as menorrhagia) during their lifetimes1.
In clinical study, Mara safely and effectively reduced heavy menstrual bleeding and improved quality of life. Mara treats patients with myomas, large cavities, and also provides post-ablation cavity access.
“I’d like to thank Maria Sainz and her team, CEO of AEGEA, for her dedication to innovation in women’s health,” Holly Sheffield, president of CooperSurgical said in a press release. “The Mara Water Vapor Ablation System gives women a great option for a safe and convenient in-office procedure to help with what can often be a debilitating health issue.”
Mara Clinical Results
One year after treatment in an international, multi-center pivotal clinical trial that enrolled 155 women, 93 percent of women reported no to moderate bleeding2. Results also demonstrated:
References
1 The American College of Obstetricians and Gynecologists. FAQ June 2016. https://www.acog.org/womens-health/faqs/heavy-menstrual-bleeding? AEGEA Medical, AEGEA Water Vapor System, SmartSeal, and IntegrityPro, and associated logos, are trademarks or registered trademarks of AEGEA Medical.
2 AEGEA Medical Instructions For Use. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160047D.pdf
3 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
About one-third of women seek treatment for heavy menstrual bleeding (also known as menorrhagia) during their lifetimes1.
In clinical study, Mara safely and effectively reduced heavy menstrual bleeding and improved quality of life. Mara treats patients with myomas, large cavities, and also provides post-ablation cavity access.
“I’d like to thank Maria Sainz and her team, CEO of AEGEA, for her dedication to innovation in women’s health,” Holly Sheffield, president of CooperSurgical said in a press release. “The Mara Water Vapor Ablation System gives women a great option for a safe and convenient in-office procedure to help with what can often be a debilitating health issue.”
Mara Clinical Results
One year after treatment in an international, multi-center pivotal clinical trial that enrolled 155 women, 93 percent of women reported no to moderate bleeding2. Results also demonstrated:
- 99 percent of patients experienced improvement in quality of life3
- 91 percent of patients satisfied or very satisfied with procedure2,3
- 93 percent said they would recommend it to a friend2
References
1 The American College of Obstetricians and Gynecologists. FAQ June 2016. https://www.acog.org/womens-health/faqs/heavy-menstrual-bleeding? AEGEA Medical, AEGEA Water Vapor System, SmartSeal, and IntegrityPro, and associated logos, are trademarks or registered trademarks of AEGEA Medical.
2 AEGEA Medical Instructions For Use. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160047D.pdf
3 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
