Latest Study Builds on Previous PACE Trials to Evaluate Cavity Access
and Feasibility of Future Interventions After Treatment for Heavy
MENLO PARK, Calif.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/AEGEA?src=hash” target=”_blank”gt;#AEGEAlt;/agt;–AEGEA Medical announced today that it has completed enrollment in the
Post-Ablation Cavity Evaluation Mexico (PACE MX) clinical study of women
who previously underwent endometrial ablation as part of a pivotal trial
of AEGEA’s Mara™ Water Vapor Ablation Treatment. The PACE MX study is
the third study of its kind, following the PACE Pilot and PACE II
studies. As in the previous PACE studies, PACE MX assesses
uterine cavity access as well as the projected feasibility of minimally
invasive diagnostic and therapeutic interventions more than four years
following uterine ablation treatment for heavy menstrual bleeding.
Furthermore, the PACE studies will evaluate the potential correlation,
if any, between ease of long- term access to the uterine cavity and
menstrual bleeding status after the water vapor ablation procedure. The
observational study enrolled 22 women at the Hospital Universitario “Dr.
José Eleuterio González“ de la Universidad Autónoma De Nuevo León (UANL)
in Monterrey, Mexico, one of the AEGEA Water Vapor Ablation pivotal
“Ease of long-term hysteroscopic uterine cavity access after endometrial
ablation is critical to a woman’s ongoing clinical care. The PACE
studies, including PACE MX, will provide important evidence to help us
better understand the longer-term implications of water vapor ablation
and the potential to preserve minimally invasive diagnostic and
treatment options,” said PACE MX study principal investigator Dr. José
Gerardo Garza Leal of UANL.
Endometrial ablation is a safe, effective and fast-growing procedure for
the treatment of heavy menstrual bleeding (menorrhagia), with the number
of U.S. cases estimated to have increased from 430,000 in 2014 to
490,000 in 2017 alone.1 As the number of procedures continues
to rise per year, studies have shown that scar tissue and re-access to
the cavity can be challenging post therapy, limiting the ability to
search for suspected cancer via biopsy, and ruling out the use of IUDs
for therapeutic intervention.2,3,4,5 In these scenarios, the
lack of post-procedure uterine cavity access often leaves women with
hysterectomy as the only viable option.
“AEGEA thanks Dr. Garza for leading this additional PACE MX study. Our
efforts to further evaluate long-term uterine cavity access post
ablation with the PACE studies are a vital addition to the growing body
of evidence supporting the safety and efficacy profile of our innovative
and natural Mara Water Vapor Ablation Treatment,” said Maria Sainz,
president and CEO of AEGEA Medical. “The PACE studies will provide women
and their physicians helpful data to assess the short-term and long-term
benefits and implications of water vapor ablation for heavy menstrual
About Mara™ Water Vapor Ablation Treatment
AEGEA’s Mara Water Vapor Ablation Treatment is the first FDA-approved
endometrial ablation procedure for heavy menstrual bleeding that is
specifically designed for use in the doctor’s office without general
anesthesia. Mara is an innovative solution for endometrial ablation that
uses water vapor to treat menorrhagia. The naturally expansive
power of water vapor ensures a safe, effective and quick treatment that
can be performed on patients with a wider range of uterine anatomies
than alternative endometrial ablation treatment options. One year after
treatment in the Pivotal Trial, 79 percent of patients reported normal
menstrual bleeding or no menstrual bleeding at all7, 91
percent of patients were very satisfied or satisfied with the procedure,
and 93 percent said they would recommend it to a friend.
About the PACE Studies
The Post Ablation Cavity Evaluation observational clinical trials were
designed to assess uterine cavity access and feasibility of future
interventions three to four years post-ablation with the Mara Water
Vapor Ablation System. The AEGEA PACE pilot study found that
post-procedure access to the mid-uterine cavity or beyond was possible
in 82 percent of the study’s 11 patients who previously participated in
a Phase II study of water vapor ablation in The Netherlands. Based on
these results, the Company launched and has completed enrollment in the
PACE II and PACE MX studies. The PACE II study enrolled 50 women at
seven sites across the U.S., with data to be released throughout 2019.
About Heavy Menstrual Bleeding (Menorrhagia)
Many women experience heavy menstrual bleeding at some point in their
lives. One in three women seek treatment for heavy menstrual bleeding.6
Healthcare professionals call this condition “abnormal uterine bleeding
(AUB)” or “menorrhagia”. The increase in quantity and duration of
menstrual bleeding can negatively impact a woman’s physical, social and
emotional well-being, and can make it difficult to engage in activities
such as work, family care, exercise and sex.
Important Safety Information
The Mara Water Vapor Ablation 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 Mara Water Vapor Ablation
System. Please refer to the device labeling for a detailed discussion of
the device’s intended use, relevant warnings, precautions, side effects,
About AEGEA Medical
AEGEA Medical is pioneering the application of its Water Vapor Ablation
technology to deliver therapies that provide high quality patient
outcomes to a wider range of patients. AEGEA’s FDA approved Mara Water
Vapor Ablation System 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.
Wortman M, Cholkeri A, McCausland A, McCausland V. Late Onset
Endometrial Ablation Failure: Etiology, Treatment and Prevention. J
Minim Invasiv Gynecol 2015; 22 323-31.
Ahonkallio SJ, Liakka AK, Martikainen HK, Santala MJ. Feasibility of
Endometrial Assessment After Thermal Ablation. Eur J Obstet Gynecol
Reprod Biol 2009 Nov; 147(1) p 69-71.
Leung PL, Tam WH, Yuen PM. Hysteroscopic Appearance of the Endometrial
Cavity Following Thermal Balloon Endometrial Ablation. Fert Steril
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Luo X, Lim CED, Li L, Wong WSF. Hysteroscopic Appearance of the
Endometrial Cavity After Microwave Endometrial Ablation. J Minim
Invasiv Gynecol 2010 17 p. 30-6.
Bruno R, McLellan R, Birdsall M, et al. Hysteroscopic Findings
Following Cryoablation – 75 Cases. JAAGL 2003; Suppl 10(3) p S17.
The American College of Obstetricians and Gynecologists. FAQ June
Medical, AEGEA Water Vapor System, SmartSeal, and IntegrityPro, and
associated logos, are trademarks and/or registered trademarks of AEGEA
Levie MD, Chudnoff SG. A Prospective, Multicenter, Pivotal Trial to
Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial
Ablation System. J Minim Invas Gynecol 2018 Jul in press article.