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 results from a 12-month prospective, multicenter, pivotal study of its AEGEA Vapor System™ were published in the peer-reviewed Journal of Minimally Invasive Gynecology (“A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System”). The data showed that the AEGEA Vapor System is a safe, effective, and minimally invasive option for performing in-office endometrial ablation under minimal anesthesia for the purpose of treating women who suffer from heavy menstrual bleeding.
“We’re committed to advancing the quality of life of premenopausal women suffering from menorrhagia,” said Maria Sainz, president and CEO of AEGEA Medical. “The publication of these study results validates the AEGEA Adaptive Vapor Ablation technology as a new alternative for women who undergo endometrial ablation, and we are gratified that The Journal of Minimally Invasive Gynecology has recognized its importance and potential.”
Conducted in private 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.
The technology proved to be safe and effective, and the study was the basis for Food and Drug Administration (FDA) approval of the AEGEA Vapor System. The technology achieved its primary effectiveness end point in 79 percent of subjects in the Intent to Treat Cohort and 85 percent in the Per Protocol Cohort. Moreover, study results showed that 99 percent of subjects experienced an improvement in quality of life and 93 percent would recommend the procedure to a friend. In addition, the study found that 90 percent of subjects were very satisfied or satisfied with the treatment. For 73 percent of women enrolled at U.S. sites, the procedure was performed in the gynecologist’s office under minimal anesthesia.
“While other ablation technologies have been available for nearly 20 years, this trial demonstrates that vapor ablation, which is unique to AEGEA, has great potential as a new treatment for menorrhagia,” said Mark D. Levie, MD, professor, Department of Obstetrics & Gynecology and Women’s Health, Albert Einstein College of Medicine. “The data show that the AEGEA Adaptive Vapor Ablation technology demonstrated extremely high patient satisfaction rates, putting forth a promising new option for physicians and patients.”
The authors also reported that:
- Seventy-two percent of women had less dysmenorrhea.
- 85 percent of women whose sex lives were affected by their menses reported improvement in their sex lives.
- There were no reported serious adverse device effects or any reported serious adverse events that were procedure related.
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 everyday 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.