AEGEA Medical, Inc., a privately held Silicon Valley company has developed a unique Adaptive Vapor Ablation technology for the in-office treatment of heavy menstrual bleeding. AEGEA Vapor System is unique because it does not require cervical dilatation, nor does the probe needs to reach the fundus like other conventional ablation systems.
Heavy menstrual bleeding (HMB) is a common entity nearly affecting 25% of the premenopausal female population and negatively impacts on the physical, emotional and social quality of life.
Endometrial ablation became a popular non-surgical alternative for treatment of HMB with the advent of hysteroscopically guided techniques. Several devices that involve the delivery of heat, cold, radiofrequency, and microwave energy are in use for endometrial ablation, each with its limitation and downside.
Endometrial ablation became a popular non-surgical alternative for treatment of HMB with the advent of hysteroscopically guided techniques. Several devices that involve the delivery of heat, cold, radiofrequency, and microwave energy are in use for endometrial ablation, each with its limitation and downside.
AEGEA Vapor System harnesses the ability of water vapor to effectively reach every part of the endometrial cavity and ablate the endometrial lining. It is the only FDA approved device with the patented Smart Seal and IntegrityPro technology.
The slender, soft tip disposable vapor probe is gently inserted in the uterine cavity without the need for cervical dilatation. The cervical color of the probe holds it securely in place. The SmartSeal technology allows for real-time monitoring of the uterine and cervical seal while the IntegrityPro technology performs patented secondary safety check to ensure correct placement of the device. It is only after the secondary safety check that vapor is initiated.
The total procedure time is 4 minutes with 2 minutes of vapor treatment, eliminating the need of any balloon, ice or other arrays. The vapor ablation can safely be performed in patients with a prior lower transverse cesarean scar, a particular type of fibroids and in the presence of Essure. It can also treat uterine cavities that are wider and up to 12 cm in length as opposed to conventional devices that can only treat cavities up to 10 cm length.
Recently, results of the 12-month prospective, multicenter, pivotal study of its AEGEA Vapor System™ were published in the peer-reviewed Journal of Minimally Invasive Gynecology. Conducted across 15 sites in the United States, Canada, Mexico, and the Netherlands, the prospective trial involved 155 perimenopausal women aged 30 to 50 years with heavy menstrual bleeding who received 120-sec vapor ablation to treat HMB.
At the end of 12 months study period, 90% of women had bleeding reduced by ≥50 percent and 99% reported an improvement in the quality of life. Additionally, 85% reported an improvement in physical intimacy after the treatment. No serious device or procedure related side effects reported.
AEGEA Vapor System also allows post-ablation uterine cavity access as shown by 11 patient data from the Pilot study. “This issue has never been addressed before and gives the vapor system a distinct advantage of the possibility of future uterine-related interventions,” said Maria Sainz, president, and CEO of AEGEA Medical in a press release.
AEGEA Medical, Inc. has announced the commencement of the Post-Ablation Cavity Access (PACE II) clinical study in women who previously underwent endometrial ablation as part of AEGEA’s pivotal trial of the company’s patented Adaptive Vapor Ablation technology. The multi-center observational study, which is being conducted at seven sites across the U.S. in up to 50 women, is designed to assess uterine cavity access as well as the feasibility of diagnostic and therapeutic interventions three to four years following treatment.
Here is an animation video about AEGEA Vapor Ablation procedure:
