Sebela Women's Health today announced the FDA granted approval of MIUDELLA (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. MIUDELLA is a hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years.
"Sebela Women's Health is thrilled to be able to bring this hormone-free IUD option for birth control to women in the United States," said Kelly Culwell, MD, Head of Research and Development, Sebela Women's Health. "Our innovative copper IUD MIUDELLA offers effective pregnancy prevention using less than half the copper of the currently available copper-based IUD in the U.S., utilizing a small, flexible nitinol frame. We believe these and other features of MIUDELLA may help address barriers to use, while also providing women with the hormone-free option some prefer."
MIUDELLA is a hormone-free IUD with a flexible frame made of nitinol, a material that has super-elastic properties that enables strategic placement of the copper in a manner that allows the device to achieve similar efficacy to the currently available copper IUD with less than half the dose of copper (175mm). MIUDELLA uses the smallest hormone-free flexible IUD frame available in the United States, measuring 32 mm horizontally and 30 mm vertically with pre-cut retrieval strings. Miudella does not require loading by a healthcare professional; it comes fully preloaded within a tapered, rounded tip inserter with a small insertion tube diameter of 3.7 mm.
"Considering it has been four decades since we've been able to offer women a new hormone-free IUD option, I find the clinical data supporting MIUDELLA efficacy and safety to be very exciting," said Principal Investigator David K. Turok, MD, MPH, Professor, Department of Obstetrics and Gynecology, University of Utah. "This innovative intrauterine device may allow for improvements in discontinuation rates due to pain and bleeding and in expulsion rates. This would be very meaningful for women looking for hormone-free options."
