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The device, called FemVue Saline-Air, was developed by Femasys Inc. for the use of evaluating a woman's fallopian tubes. The device attaches to existing ultrasound equipment that most offices already have and allows the physician to quickly and inexpensively evaluate a woman's fallopian tubes for blockage – one of the leading factors contributing to infertility. This type of fallopian tube evaluation in the past has typically been referred out to diagnostic centers who use radiology-driven technology known as hysterosalpingography (HSG). This procedure requires that a woman receive a small amount of dye that is placed in the vagina and flows through the uterus and fallopian tubes. Once the dye is inserted then X-ray images are taken to reveal whether or not there is a blockage or other abnormal structure of the tubes which could cause infertility. The new FemVue device, instead, would allow doctors to view the internal structures of a woman's fallopian tubes in office without the use of dye or X-ray radiation. Dr. Charles E. Miller, President and Medical Director of the Advanced Gynecologic Surgery Institute, remarked, "I see FemVue as a marked improvement over standard fluoroscopic HSG. It allows me the ability, in the office, to precisely evaluate the cavity, myometrium, and for the first time fallopian tubes. It is my diagnostic procedure of choice for evaluating fallopian tubes." However, not all doctors agree that this ultrasound device is an acceptable replacement diagnostic device for the traditional HSG, which has previously been accepted as the superior mode of visualization of the woman's reproductive structures. “Contrary to what Charles Miller is quoted saying, ultrasound can never compete with radiological assessment of fallopian tubes,” says Norbert Gliecher, MD., founder of the Center for Human Reproduction, a well-recognized IVF New York based infertility center. “The reason this company produces an ultrasound is not because it is better than a radiology study but because nobody has [their own radiology center] and everybody has an ultrasound machine.” Fallopian tube evaluation is a first line diagnostic used to evaluate a woman when she is having difficulty becoming pregnant. Scarring from infection, polyps, fibroids or injury could all cause a blockage in a fallopian tube. Endometriosis infertility is also generally caused by endometrial adhesions which can obstruct the tubes. If a tube is blocked then the egg and sperm are unable to move through the tubes to fertilize, rendering a woman infertile. In some cases, the dye inserted in the HSG procedure is enough to clear the obstruction whereas other times further infertility treatment is necessary to clear the obstruction. The FemVue is already currently available for use in some states and the company expects that this new approval will make the FemVue a standard device in many practices. Kathy Lee-Sepsick, President & CEO of Femasys Inc. said, ""The FemVue clearance for commercialization represents a significant step forward for the growth of the company. FemVue not only provides the physician an ability to expand services but allows for a comprehensive and appropriate plan of care, saving time and cost for the patient, both invaluable for couples dealing with infertility issues." |
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Infertility Diagnostic FemVue Approved by FDA, Sparks Controversy