Heavy bleeding during menstruation, known as menorrhagia, is often treated by endometrial ablation. There’s a number of methods of doing so, including delivery of heat, cold, and microwaves, but each has a number of downsides and limitations.
AEGEA Medical is a Silicon Valley company that has developed a unique technology, called adaptive vapor ablation, that allows physicians to treat menorrhagia in a five minute procedure that doesn’t require cervical dilation, nor any direct contact with the uterine fundus.
We were curious and wanted to find out more and had an opportunity to pose a few questions to Maria Sainz, the President and CEO of AEGEA Medical.
Medgadget: Endometrial ablation is currently performed using microwave energy, radiofrequency energy, or direct heat or cold. What are the downsides of these methods in practice?
Maria Sainz, President & CEO of AEGEA Medical: Physicians have performed endometrial ablation for over 15 years to treat menorrhagia, or heavy menstrual bleeding. Endometrial ablation is intended only for premenopausal women who no longer want to have children in the future. Historically, procedures have typically been performed in the operating room with the majority of patients being put under general anesthesia. Consequently, the procedure itself has traditionally been involved and the recovery has been prolonged for a patient. There has been an increasing desire to move procedures to an office setting, which can be easier and more comfortable for patients, and more convenient for physicians.
Medgadget: Can you describe how the AEGEA system differs and how it works?
Sainz: The AEGEA Vapor System is the first FDA-approved endometrial ablation system specifically designed for use in the doctor’s office. Rapid and easy to perform without use of general anesthesia, AEGEA provides a new treatment option for menorrhagia. Patient recovery times are short, with the majority of patients returning to work within two days or less.
The AEGEA system is the only endometrial ablation product that uses water vapor for treatment. Harnessing the ability of natural water vapor to efficiently conform to each woman’s unique anatomy, the system enables the ablation medium to be delivered through a very small and flexible probe that does not require dilation or uncomfortable high pressure within the uterine cavity. Low pressure water vapor (water in a gas state) has been demonstrated in clinical trials to safely and uniformly expand inside the uterine cavity and transfer thermal energy to the uterine wall. The efficiency of water vapor to carry and distribute energy enables the rapid two-minute treatment time. The conformability of vapor also enables efficient treatment of a broader range of patients compared to prior endometrial ablation therapies.
The AEGEA Vapor System has two parts: the re-usable Vapor Generator and the disposable Vapor Probe. The Vapor Generator has an intuitive touch screen with instructions; the Vapor Probe has a small flexible tip through which vapor is delivered to the uterus, and the system uses first-in-class safety features.
Medgadget: What are the procedural benefits from the point of view of the physician?
Sainz: The AEGEA Vapor System is an in-office treatment option for endometrial ablation that is safe, simple and effective, as demonstrated in the company’s pivotal trial data that was the basis for FDA approval. Seventy-three percent of the U.S. procedures from the pivotal trial were performed in the office setting. No serious device or procedure-related adverse events were reported through the study’s 12-month clinical follow-up. The majority of patients had a reduction of their menstrual bleeding to normal levels or had no period at all. Treatment time is two minutes, and the system is fully automated.
The AEGEA Vapor System enables a broader spectrum of patients to have access to endometrial ablation. Vapor ablation treats larger cavities (up to 12 cm in uterine cavity length) as well as cavities with certain fibroid types. Competitive devices can only treat uterine cavity lengths up to 10 cm and did not include women with fibroids in their FDA trials.
In addition, a new research study is underway to evaluate uterine cavity access following endometrial ablation. AEGEA believes this is a very important success metric for the therapy, as it speaks to the possibility of future uterine-related interventions. Pilot data on 11 patients treated with Adaptive Vapor Ablation technology has demonstrated that Vapor Ablation has the potential address this unmet need, potentially preserving physician and patient options in the future.
Medgadget: What about the outcomes? What should patients expect?
Sainz: One year after the treatment in the pivotal study, the following results were seen:
6X reduction in menstrual bleeding per pivotal study criteria
90 percent had bleeding reduced by ≥50 percent
85 percent had bleeding that was reduced to a normal level or less per scientific literature
99 percent experienced an improvement in quality of life 12 months post-treatment
93 percent would recommend the procedure to a friend
91 percent were satisfied or very satisfied 12 months after the procedure
Additionally, 85 percent of patients whose periods affected their sex lives reported an improvement in their sex life after treatment.
The pivotal trial data showed that the AEGEA Vapor System was safe, with no serious device or procedure-related adverse events reported. The reported adverse events were consistent with the anticipated types and frequency of adverse events reported from previous studies of endometrial ablation devices that have FDA approval.
As stated above, patient recovery times are short, with the majority of patients returning to work within two days or less.
Medgadget: What is your current regulatory status in the U.S. and otherwise?
Sainz: The AEGEA Vapor System is FDA approved to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. Regulatory approvals outside of the U.S. are under evaluation.
Medgadget: How has your system been adopted where you have been marketing it so far?
Sainz: AEGEA is currently developing a next generation ablation system with the business objective of developing a scalable manufacturing platform. Commercialization is expected to occur in 2019.
Medgadget: What are you hearing from patients and physicians?
Sainz: A number of physicians and patients in the company’s pivotal trial provided testimonials about their experience with vapor ablation. Representative statements are provided below:
Here’s an animation describing the AEGEA Vapor Ablation procedure:
Disclaimer: As with all surgical procedures, there are risks and considerations associated with 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. Patient and Physician labeling are provided on the AEGEA website, www.aegeamedical.com.
Info page: AEGEA Vapor System…