AEGEA Vapor System
The AEGEA Vapor SystemTM is currently in clinical trials under an Investigational Device Exemption in the United States. The AEGEA Vapor System is currently limited by United States Federal Law to Investigational Use.
The AEGEA Vapor System utilizes water vapor to treat menorrhagia. Menorrhagia, or menstrual periods with abnormally heavy or prolonged bleeding, affects nearly 1 in 5 women between the ages of 30 and 50. To treat abnormal uterine bleeding, the AEGEA Vapor System is designed to deliver controlled, low-pressure clean and efficient water vapor to the uterine cavity to efficiently ablate the inner lining of the uterus.
AEGEA Vapor System Advantages
By efficiently converting sterile water into naturally expansive vapor and delivering it to the uterine cavity via a controlled, low-pressure system, the AEGEA Vapor System may provide distinct advantages over existing menorrhagia treatment options for physicians, patients, medical centers, and payers, including:
- Small diameter device (<6mm) utilizing a micro profile probe with a flexible distal tip for easy physician insertion to minimize uterine manipulation
- Simple, intuitive 2-minute treatment designed to be delivered as an in-office procedure
- Designed to accommodate a wide range of uterine cavities
- Active and continuous software-driven safety monitoring
The AEGEA Vapor System is not commercially available in the United States. The assumptions above are being studied under an Investigational Device Exemption approved by the FDA.
Treatment with the AEGEA Vapor System is designed to minimize complications and/or side effects seen with medications or other more invasive procedures to treat menorrhagia. The benefits of the AEGEA Vapor System are currently being studied in a clinical trial.