ExEm® Foam ([air polymer-type A] intrauterine foam; ExEm Foam Inc), a contrast agent for ultrasound tubal patency testing, is now available at select fertility clinics nationwide.
ExEm Foam is indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility. Coupled with the Foam procedure (hysterosalpingo foam sonography [HyFoSy], the imaging technique takes, on average, less than 15 minutes and provides real-time results.
The approval was supported by data from 2 clinical studies that compared HyFoSy with ExEm Foam using 2D- and 3D-imaging to previous laparoscopy with chromotubation. Findings showed that for 2D imaging, the proportion of fallopian tubes correctly identified as occluded was 80% and those correctly identified as patent was 92%. For 3D imaging, the proportion of fallopian tubes correctly identified as occluded was 98% and those correctly identified as patent was 91%. The diagnostic performance of 2D- and 3D-HyFoSy was also found to be similar to that seen with 2D- and 3D-HyFoSy with high-definition flow Doppler enhancement.
Additionally, compared with X-ray hysterosalpingography (HSG), the outpatient tubal assessment with ExEm Foam was associated with significantly lower pain scores and does not require the use of radiation and iodine.
The most common adverse reactions reported with ExEm Foam include pelvic and abdominal pain, vasovaginal reactions and associated symptoms such as nausea and faintness, and post-procedure spotting. ExEm Foam is contraindicated in pregnancy, and in patients with: known or suspected lower genital tract inflammation/infection; gynecologic procedure within the last 30 days; vaginal bleeding; and known or suspected reproductive tract neoplasia.
“Cutting-edge, safe and effective diagnostic procedures, like the Foam procedure, allow us to quickly and as comfortably as possible identify fertility issues and plan the next step in a patient’s fertility journey,” said Professor Mark Hans Emanuel, MD, PhD, Department Gynecology and Reproductive Medicine, University Medical Center Utrecht, The Netherlands, and co-inventor of the Foam procedure.
ExEm Foam is supplied as a single-dose kit containing 2 syringes and 1 Combifix® Adaptor (coupling device).
For more information visit exemfoam.com.
1. ExEm® Foam, the only FDA-approved contrast agent for ultrasound tubal patency testing, now available in the U.S. [press release]. Nashville, TN: ExEm Foam; February 17, 2021.
2. ExEm® Foam [package insert]. New York, NY: ExEm Foam Inc; 2021.