MENLO PARK, Calif.--(BUSINESS WIRE)--AEGEA Medical, Inc., a privately held medical device company focused on the development of its patented Adaptive Vapor Ablation technology, has announced that 36-month follow-up data from a prospective, multicenter, pivotal study of its AEGEA Vapor System™ were presented at the AAGL Global Conference on Minimally Invasive Gynecologic Surgery in Las Vegas on November 13. The data showed that the AEGEA Vapor System is a safe, effective and minimally invasive option for in-office endometrial ablation that delivers lasting results and consistent high patient satisfaction three-years post treatment.
“We are very encouraged by these positive data, as they show that the results of Adaptive Vapor Ablation stand the test of time,” said Maria Sainz, president and CEO of AEGEA Medical. “These three-year follow-up data should assure physicians and patients that our innovative and natural vapor-based treatment will successfully deliver sustained safe and effective outcomes including improved quality of life.”
Conducted in office and outpatient hospital settings at 15 sites in the United States, Canada, Mexico and the Netherlands, the prospective, multi-center, single-arm, open-label, clinical trial was designed to evaluate endometrial ablation (120-second treatment time) in 155 perimenopausal women aged 30 to 50 years with heavy menstrual bleeding. In order to be eligible for the trial, patients were required to have at least two times the normal level of bleeding. Enrolled patients also included those with large uterine cavities, certain types of myomas and the presence of an Essure® device.
At 36-month follow-up, the safety and effectiveness of Adaptive Vapor Ablation proved to be durable and consistent, with 95 percent of patients reporting normal menstrual bleeding or no menstrual bleeding at all, 92 percent of patients continuing to be very satisfied or satisfied with the procedure, and 95 percent saying they would recommend it to a friend.
“Since the treatment three years ago, my periods have gone from five to seven days of very heavy bleeding to two or three days of light spotting. I don’t have that fear of soaking through my clothes anymore,” said Melanie Phillips, a nurse and mother of two who completed her three-year follow-up in the AEGEA pivotal trial. “The vapor procedure itself was surprisingly quick and I was back to my normal activities the next day. I highly recommend this treatment to other women who may be suffering with heavy menstrual bleeding.” In the clinical study, the majority of patients returned to normal daily activities within two days after treatment.
Mark D. Levie, MD, professor, Department of Obstetrics & Gynecology and Women’s Health, Albert Einstein College of Medicine, and principal investigator of the AEGEA pivotal study, commented, “These results give me great confidence in AEGEA’s Adaptive Vapor Ablation procedure. It’s safe and effective, and it delivers the long-term outcomes we are looking for as physicians. I believe Adaptive Vapor Ablation is a valuable new option for treating women with menorrhagia.”
About Excessive Menstrual Bleeding (Menorrhagia)
Many women experience heavy menstrual bleeding at some point in their lives. Nearly 1 in 5 women between the ages of 30 and 50 experience abnormally heavy or prolonged menstrual bleeding. Healthcare professionals call this condition “abnormal uterine bleeding (AUB)” or “menorrhagia”. The increase in quantity and duration can negatively impact every day routine activities such as work and family care. It can also make it difficult to exercise and to be socially or sexually active.
Important Safety Information
The AEGEA Vapor System is indicated for premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. As with all surgical procedures, there are risks and considerations associated with the use of the AEGEA Vapor System. Please refer to the device labeling for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications.
AEGEA Medical is pioneering the application of its Adaptive Vapor Ablation technology to deliver therapies that provide high quality patient outcomes to a wider range of patients. AEGEA’s FDA approved water vapor technology enables the delivery of a safe and effective endometrial ablation for the treatment of menorrhagia in a simple, office-based procedure that takes only minutes. With a vision to expand safe and effective treatment options to more patients, and provide physicians with the confidence and convenience necessary to perform office-based procedures, AEGEA is inspiring new approaches to women’s healthcare. Founded in 2008, AEGEA Medical is located in Menlo Park, Calif. For more information, visit AEGEAmedical.com.
AEGEA Medical, AEGEA Vapor System, SmartSeal, and IntegrityPro, and associated logos, are trademarks and/or registered trademarks of AEGEA Medical.