Irish pharmaceutical firm Allergan and nonprofit women's health pharmaceutical company, Medicines360, will introduce the levonorgestrel-releasing intrauterine system (LILETTA) 52mg IUD single-handed inserter (intrauterine device) for pregnancy prevention of up to three years.
LILETTA is a hormone-releasing system implanted in a woman's uterus to prevent pregnancy.
It can be used by women regardless of their parity or body mass index (BMI) and can be fitted on the same day of their visit to the clinic.
LILETTA is not a permanent procedure and can be removed at anytime by the healthcare provider, thereby making the device flexible to be used for long and short-term contraception.
Medicines360 CEO Jessica Grossman 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.
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"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."
LILETTA’s approval was the result of the largest hormonal IUD trial named as the A Comprehensive Contraceptive Efficacy & Safety Study of an IUS (ACCESS IUS).
The trial involved 1,751 women who received LILETTA.
Results suggested safety and efficacy of the device on a broad range of women recording a success rate of the single-handed inserter as 99.2%.