Brand Name
ExEm
Generic Name
Polymer-Type
View Brand Information FDA approval date: October 16, 2020
Form: Kit
What is ExEm (Polymer-Type)?
ExEm ® Foam is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility. ExEm ® Foam is an ultrasound contrast agent indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.
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Is, in Infertile Women Undergoing a Basic Fertility Work-up, Tubal Flushing With Oil-based Contrast Medium During Hysterosalpingography (HSG) Cost-effective Compared to Tubal Flushing by Hysterosalpingo-foam Sonography (HyFoSy)?
Summary: Hysterosalpingography (HSG) and hysterosalpingo-foam sonography are two methods to assess tubal patency during fertility work-up. This study aims to investigate the effectiveness of tubal flushing with oil-based contrast during HSG compared to tubal flushing during HyFoSy in women undergoing fertility work-up. The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more l...
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Brand Information
ExEm Foam (Air Polymer-Type A Intrauterine Foam)
1INDICATIONS AND USAGE
ExEm
2DOSAGE FORMS AND STRENGTHS
Intrauterine Foam, single-dose kit containing:
- Syringe A: one syringe with 5 mL clear Gel [polymer-type A (hydoxyethyl cellulose), glycerin and purified water]
- Syringe B: one syringe with 5 mL Sterile Purified Water
- One Combifix Adaptor (coupling device)
When prepared as directed ExEm Foam will contain between 10,000 to 127,000 bubbles per mL.
3CONTRAINDICATIONS
ExEm Foam is contraindicated for use in:
- Pregnancy
- Patients with known or suspected lower genital tract inflammation or infection
- Patients who have had a gynecologic procedure within the last 30 days
- Patients with vaginal bleeding
- Patients with known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm
4DESCRIPTION
ExEm Foam (air polymer-type A) intrauterine foam, is an ultrasound contrast agent. It is provided to the user for preparation as a single-dose kit containing:
- 5 mL sterile clear Gel [polymer-type A (80.97 mg hydroxyethyl cellulose), 434.80 mg glycerin 85%, and purified water]; with a pH of 6 to 7.5.
- 5 mL Sterile Purified Water; with a pH of 6 to 7.5.
After preparation, ExEm Foam is a milky-white, water-soluble intrauterine foam with an osmolality of approximately 462 mOsm and will contain between 10,000 to 127,000 bubbles per mL with a median size of 45.6 to 60.6 micrometers (for bubbles between 20 to 200 micrometers).
5NONCLINICAL TOXICOLOGY
No nonclinical toxicology studies have been conducted with ExEm Foam. Glycerol-hydroxyethyl cellulose (HEC) Gel is not genotoxic (Ames test) or cytotoxic (mouse lymphoma L5178Y TK+/- assay).
6CLINICAL STUDIES
Clinical studies reported in the scientific literature have assessed the performance of sonohysterosalpingography with ExEm Foam (a technique referred to as HyFoSy) for the diagnosis of tubal patency in women with infertility. The studies used laparoscopy with chromotubation as the reference standard.
Study A compared 2D- and 3D-HyFoSy to previous laparoscopy with chromotubation in 50 women (median age 35 years) with at least 12 months of infertility (median duration of infertility 28 months). The women were randomly assigned to either HyFoSy with 2D imaging or HyFoSy with 3D imaging. The operator performing HyFoSy was blinded to the laparoscopy results. For 2D imaging, the proportion of fallopian tubes correctly identified as occluded was 80% and the proportion of tubes that were correctly identified as patent was 92%. For 3D imaging, the proportion of tubes correctly identified as occluded was 98% and the proportion of tubes that were correctly identified as patent was 91%.
Study B compared the diagnostic performance of HyFoSy with ExEm Foam using both 2D/3D-sonohysterosalpingography (2D/3D-HyFoSy) and 2D/3D-HyFoSy with high-definition flow Doppler enhancement (2D/3D-HDF-HyFoSy), to the reference standard of laparoscopy with chromotubation to establish the patency of the tubes. The study evaluated 132 women (259 fallopian tubes) with history of primary or secondary infertility who were consecutively enrolled over a period of 2 years. The mean age was 32 years and the mean duration of infertility was 2.6 years. The performance of 2D/3D-HyFoSy was similar to that of 2D/3D-HDF-HyFoSy. The performance estimates in Study B were numerically similar to those reported in Study A.
7PRINCIPAL DISPLAY PANEL - Kit Carton
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