Allergan, a well known pharma firm, and Medicines360, a nonprofit pharma firm focusing on women’s issues, are releasing the new LILETTA (levonorgestrel-releasing intrauterine system) 52 mg intrauterine device single-handed inserter.
The tool was designed to make the placement of an IUD more consistent and easier due to its one-handed operation, which can be done using either the left or right hand. The tube that’s inserted is bendable and will conform to patient anatomy as it’s pushed toward the uterus.
The device is reloadable if placement proves challenging and it comes down to trying it again.
Some details according to a Medicines360 announcement:
The approval of the new single-handed inserter was based on the largest hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS), conducted in the U.S. with 1,751 enrolled women receiving LILETTA, the same trial that supported the initial approval of LILETTA. LILETTA was shown to be safe and effective for a broad range of women, with a cumulative three-year efficacy rate of 99.45 percent. LILETTA is indicated for women regardless of parity or Body Mass Index (BMI) and can be inserted on the same day she visits the clinic, providing that she is not pregnant. During the ACCESS IUS clinical trial, the success rate for insertions with the new single-handed inserter was 99.2%.
LILETTA is a hormone-releasing system placed in a woman’s uterus to prevent pregnancy for up to three years and is greater than 99% effective. LILETTA is not permanent, it can be removed at any time by a healthcare provider, offering the flexibility of use for either long- or short-term contraception. LILETTA can be used in women regardless of whether or not they’ve birthed a child. Allergan initially launched LILETTA in partnership with Medicines360, a non-profit global pharmaceutical company whose mission is to provide access to medicines for women regardless of their socioeconomic status, insurance status, or geographic location. The new LILETTA single-handed inserter with an optimized package received approval in May 2016, and will succeed the two-handed inserter, which was approved by the U.S. FDA in February, 2015.
Source: Medicines360…
