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Portland-based Women’s Health Center is Leading the Pacific Northwest as the First to Offer an In-Office Treatment Using N

PORTLAND , July 15 /Businesswire/ - Pearl Women’s Center today announced that it is now offering the Mara™ Water Vapor Ablation System from AEGEA Medical for the treatment of heavy menstrual bleeding. Mara is the only endometrial ablation treatment that utilizes natural water vapor to safely treat heavy menstrual bleeding. It is the first FDA-approved endometrial ablation procedure that is specifically designed for use in the doctor’s office. The procedure does not require incisions and can be performed without the need for general anesthesia. The Pearl Women’s Center is currently open and taking appointments, while ensuring the safety of their patients by practicing CDC-recommended COVID-19 precautions.

Heavy menstrual bleeding, also known as menorrhagia, can cause enough bleeding to soak through a sanitary napkin every hour for several hours or days in a row. The increase in quantity and duration of menstrual bleeding can negatively impact a woman’s physical, social and emotional well-being. Many women experience heavy menstrual bleeding at some point in their lives and about one-third of women seek treatment for this condition.1

Mara is a one-time, two-minute in-office treatment that uses natural water vapor to gently eliminate the lining of the uterus, the source of heavy menstrual bleeding in women who have not reached menopause. When eliminated, the lining can no longer re-grow to cause heavy menstrual bleeding. Mara is only for women who no longer want to become pregnant in the future.

“We are proud to be the first practice in the Pacific Northwest to offer the Mara treatment,” said Dr. Richard Rosenfeld, the Pearl Women’s Center founder and executive medical director. “We are dedicated to offering the highest level of care possible to address the unique needs of our patients and believe that the addition of Mara to our treatment offerings demonstrates this commitment. With Mara, we are able to safely and effectively treat heavy menstrual bleeding in the convenience of our office.”

Mara has been shown in a clinical trial to safely and effectively reduce heavy menstrual bleeding and improve quality of life. One year after treatment, 79 percent of patients had their heavy menstrual bleeding reduced to a normal level or less, 99 percent of patients experienced an improvement in their quality of life, 91 percent of patients were very satisfied or satisfied with the procedure, and 93 percent said they would recommend it to a friend.2,3 Moreover, sustained results were reported three years after treatment.2,4

About Mara™ Water Vapor Ablation Treatment

Mara Water Vapor Ablation Treatment is the first FDA-approved endometrial ablation procedure for heavy menstrual bleeding that is specifically designed for use in the doctor’s office without the need for general anesthesia. By utilizing the naturally expansive properties of water vapor, Mara safely and effectively treats patients with a wider range of uterine anatomies than alternative endometrial ablation treatment options. One year after treatment in the pivotal trial, 79 percent of patients had their heavy menstrual bleeding reduced to a normal level or less, 99 percent of patients experienced an improvement in their quality of life based on MIQ (Menorrhagia Impact Questionnaire) scores, 91 percent of patients were very satisfied or satisfied with the procedure, and 93 percent said they would recommend it to a friend.2,3 Sustained results were reported three years after treatment.2,4 Over the 36-month duration of the trial, there were 10 (6.5% percent, 10/155) reported hysterectomies.2,4 There were no reported serious adverse device effects (SADEs), nor any reported serious adverse events (SAEs) that were procedure related.2,3

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 at https://maratreatment.com/ for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications.

About Pearl Women’s Center

Pearl Women’s Center was founded in 2005 by Dr. Richard Rosenfield, a forward thinking, board-certified gynecologist. Located in Portland in the heart of the Pearl District, the mission of our practice is to bring together highly skilled, board-certified specialists in key areas of women’s health. Through a focused approach to women’s health needs, we provide a higher level of care in an ever-evolving and complex area of medicine. With services provided in gynecologic surgery, varicose vein management, bioidentical hormone management (BHT), as well as naturopathic medicine, Pearl Women’s Center is unique in the Portland metro area. Choose the specialists at Pearl Women’s Center for every stage of your life.

COVID-19 Safety Information

The Pearl Women’s Center is open and currently offering both telehealth and in-office appointments. Should you require an in-office visit, the specialists at Pearl Women’s Center are following CDC recommendations and guidelines to ensure the safety of our staff and patients.

References

  1. The American College of Obstetricians and Gynecologists. FAQ June 2016.

    https://www.acog.org/patient-resources/faqs/gynecologic-problems/heavy-menstrual-bleeding

    Medical, AEGEA Water Vapor System, SmartSeal, and IntegrityPRO, and associated logos, are trademarks and/or registered trademarks of AEGEA Medical.
  2. AEGEA Medical Instructions for Use.
  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.
  4. Levie H, et al. Endometrial Ablation Using Water Vapor: 36-Month Follow-up. J Minim Invasiv Gynecol 2018 25 (7) Suppl S46.

 


STORY TAGS: Contract/Agreement, Product/Service, Medical Devices, Health, Consumer, Surgery, Women, Baby/Maternity, Alabama, United States, North America,

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