Aegea Medical device to treat heavy menstrual bleeding wins FDA approval
Aegea Medical this week said it won FDA approval for its Mara Water Vapor Ablation System.
The Mara System is an endometrial ablation treatment that uses natural water vapor to treat menstrual bleeding. It is designed to be used in a doctor’s office without the need for general anesthesia.
Mara is a one-time, two-minute treatment that gently eliminates the lining of the uterus using natural water vapor. Once the lining is removed, it can no longer re-grow and cause heavy menstrual bleeding.
“Endometrial ablation is a commonly used procedure for heavy menstrual bleeding,” Kirk Brody, a board-certified obstetrician-gynecologist, said in a news release. “I believe Mara with its natural water vapor technology and safety features will bring my patients a better treatment experience and positive outcomes.”
Because of the properties of water vapor, Mara is able to conform to each woman’s uterus and is FDA approved to treat women with a number of uterine anatomies.
“We at Aegea have dedicated ourselves to pioneering a new water vapor ablation technology we believed held enormous potential to safely, effectively and conveniently benefit the number out women with heavy bleeding,” president and CEO Maria Sainz. “We are proud to now introduce Mara, an in-office treatment intended to bring physical, social and emotional relief to women who suffer from heavy menstrual bleeding and to enable physicians to offer this treatment option to a greater range of patients than previously thought possible.”
A clinical study of the Mara showed it reduced heavy menstrual bleeding and improved quality of life. One year after treatment in an international, multi-center pivotal clinical study with 155 women, 79% of patients had their heavy menstrual bleeding reduced to a normal level or less, 99% of patients showed an improvement in the quality of life, 91% of patients were very satisfied or satisfied with the procedure and 93% would recommend the procedure to a friend.
“Although common, menorrhagia can have an outsized negative impact on women’s lives and has long been challenging to treat,” David Adair, chairman of the board of directors, said. “Mara will be an important new treatment option that will enable my colleagues in the OB/GYN community to expand and elevate the level of care they can provide to women suffering from menorrhagia.”