Sebela Women’s Health announced that the U.S. Food and Drug Administration approval of Miudella, a hormone-free copper intrauterine system designed to prevent pregnancy for up to 3 years. 

The approval represents the first new copper intrauterine device (IUD) approved in the United States in over 40 years, according to a press release from Sebela Women's Health. The novel IUD features a nitinol frame, allowing strategic copper placement with less than half the copper dose of currently available copper IUDs. The device measures 32 mm by 30 mm and is preloaded in a 3.7-mm insertion tube, eliminating the need for manual loading.

Approval was based on three U.S. clinical trials involving 1,904 women aged 17 to 45 years. In the phase III study (n = 1,397), the novel IUD demonstrated a first-year Pearl Index of 0.94 (95% confidence interval [CI] = 0.43–1.78) and a cumulative 3-year Pearl Index of 1.05 (95% CI = 0.66–1.60), indicating 99% contraceptive efficacy. Placement success was reported at 98.8%. Adverse events included heavy menstrual bleeding, dysmenorrhea, and intermenstrual bleeding, with incidence declining over time. Discontinuation as a result of bleeding or pain occurred in 8.5% of participants in year 1 and 3.2% by year 3. Expulsion rates ranged from 1.9% in year 1 to 0.9% in year 3.

The American College of Obstetricians and Gynecologists stated that long-acting reversible contraception, including IUDs, is among the most effective methods, with few contraindications and broad patient eligibility. Unintended pregnancies accounted for 41.6% of pregnancies in the United States.

The novel IUD will be available through trained health care providers in 2025 under a Risk Evaluation and Mitigation Strategy program requiring health care provider training to ensure proper insertion.