New Single Handed IUD Inserter for LILETTA released easing IUD insertion.

Courtesy: Liletta.com

Allergan a leading global pharmaceutical company, and Medicines360, a nonprofit global women's health pharmaceutical company, recently launched the new LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg IUD single-handed inserter (intrauterine device), for use by women to prevent pregnancy for up to three years. The system needs to be replaced after 3 years if continuous protection is desired.                                                                                                    

The launch and availability of the single-handed inserter came in the wake of U.S. Food and Drug Administration (FDA) approval received in January 2016.

The FDA approved it after the results of the largest hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS). The study enrolled 1751 women to have LILETTA inserted. It was shown to be safe with a cumulative three-year efficacy rate of 99.45 percent. It was effective in broad range of women irrespective of ethnicity, BMI and parity. The study included women aged 16-45 years with 58% nulliparous and 42% multiparous.

It can be inserted as an office procedure and the success rate with the single-handed inserter is 99.2%. The new single handed inserter has a bendable tube which adapts to the anatomy of the uterus. Two color coded blue and green sliders help to load the Intra Uterine System(IUS) during insertion and open the arms at the time of release. The device can be reset if not loaded properly.

Courtesy: Liletta.com

Allergan and Medicines360 have launched a comprehensive product demonstration programme in private and public sector.

The contraindications, risk factors and complications are similar to other levonorgestrel-releasing intrauterine system IUS.

Jessica Grossman, MD, CEO of Medicines360 said “We are excited to bring to market the new LILETTA inserter and anticipate that the single-handed process may lead to broader use by healthcare providers, thereby increasing the number of women who have access to this effective contraceptive.” She further added “Specifically, the new LILETTA inserter includes an ergonomic design allowing for single-handed insertion that can be used with either hand; a bendable tube to accommodate the anatomy of the patient during insertion; and the ability to reload the device if needed before insertion.”

The cost of Liletta for an uninsured patient is $50.