ELEVATING UTERINE HEALTH
About the Juveena® Hydrogel System
The Juveena Hydrogel System is indicated for use in adult women to reduce the incidence and severity of intrauterine adhesion formation following hysteroscopic adhesiolysis for symptomatic moderate to severe intrauterine adhesions. .
The Rejoni Acorn Catheter is indicated to access the uterine cavity and deliver the Juveena Hydrogel solution into the uterine cavity.
The Juveena Hydrogel System should not be used in presence of:
- Hemorrhage
- Active pelvic infection
- Sexually transmitted disease
- Pregnancy
- Known hypersensitivity or allergy to Polyethylene Glycol (PEG) or FD&C Blue #1 dye
KEY FEATURES & BENEFITS
Juveena is intended to reduce the incidence and severity of intrauterine adhesions following hysteroscopic adhesiolysis.
Low-profile 1.4mm transcervical catheter with tapered Acorn tip for ease-of-positioning and sealing external cervical os.
The hydrogel conforms to the uterine cavity and remains in place to create a favorable environment for the uterine lining to heal by providing both space and time for recovery.
The composition of the hydrogel is designed to liquify after 14-21 days. (or one menstrual cycle) therefore no secondary follow-up procedure needed for removal.
Clinicians and women can trust using Juveena after hysteroscopic adhesiolyis to reduce the risk and severity of developing IUAs. Juveena has been clinically evaluated in patients with moderate to severe adhesions.
Important Safety Information: The Juveena Hydrogel System is indicated for use in adult women to reduce the incidence and severity of intrauterine adhesion formation following hysteroscopic adhesiolysis for symptomatic moderate to severe intrauterine adhesions. The Juveena Hydrogel System should not be used in patients with hemorrhage, active pelvic infection, sexually transmitted disease, or pregnancy, or in patients with known hypersensitivity or allergy to polyethylene glycol (PEG) or FD&C Blue #1 dye. Safety and effectiveness have not been established following hysteroscopic procedures other than adhesiolysis of moderate to severe intrauterine adhesions, or in patients undergoing thermal endometrial ablation. Patients should avoid pregnancy during the first complete menstrual cycle after treatment. Potential adverse reactions include discomfort, pain/cramping, infection, local inflammatory reaction, and allergic reaction. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner. For complete information, see the Instructions for Use.
What are intrauterine adhesions(IUAs)?
Intrauterine Adhesions (IUAs), happen when scar tissue forms inside the uterus or cervix.1,2 This can occur after an injury to the uterus, such as surgery or a complicated pregnancy, which causes the lining to heal with bands of tissue. These adhesions can be thin or thick and may cover small or large areas. Doctors classify IUAs as mild, moderate, or severe based on how much scar tissue is present.
the problem
IUAs affect more patients than recognized.
Intrauterine adhesions form when scar tissue develops inside the uterus following surgical procedures or pregnancy complications. They are frequently under-diagnosed. Standard exams such as ultrasound often miss them and can silently compromise fertility in women of reproductive age.1
16%
after hysteroscopic myomectomy
17%
after a D&C in early pregnancy loss
Even after hysteroscopic adhesiolysis, intrauterine adhesions can return. In women with moderate to severe disease, recurrence has been reported in up to 32.5% of cases.2
IUAs can also develop after surgery for:
• Repeat adhesion removal
• Fibroid removal
• Excessive uterine bleeding
• Uterine Septums
Scientific Publications
Why Juveena
Presentation/Abstracts/Posters
UTERINE ADHESION RESOURCES
Patient and Physician Communities
