Allergan and Medicines360 are launching a new single-handed inserter for their Liletta intrauterine device. The FDA green-lighted the new insertion device in January this year.
Liletta is a hormonal IUD that is currently inserted by a clinician using a two-handed inserter. It competes with three other IUDs in the U.S.: Teva’s Paragard, which is delivered via a two-handed inserter, and Bayer’s Mirena and Skyla, which both use single-handed inserters. Unlike Bayer’s devices, which are not reloadable, the new Liletta inserter is, meaning that if the IUD is loaded incorrectly in the insertion device, the doctor may reposition and reload it, Medicines360 CEO Dr. Jessica Grossman told FierceMedicalDevices. The single-handed inserter also has a long, bendable tube, which can accommodate a variety of anatomical structures, such as a retroverted uterus, 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,” Grossman said in the statement.
The companies are conducting a comprehensive product demonstration program to introduce the new inserter to clinicians, according to the statement. They hope to phase out the original two-handed Liletta inserter over the next several months, Grossman said.
While their goal is to completely phase out the old inserter in the U.S., a two-handed inserter is not necessarily a barrier to Liletta’s adoption. After all, the copper Paragard uses one, and so does the rest of the world, Grossman said. But U.S. physicians are accustomed to Bayer’s IUDs, which were approved in 2009 and 2013, and have single-handed inserters. The barrier is the perception that a single-handed inserter is better, Grossman said.
In fact, Liletta was shown in a U.S. trial enrolling 1,751 women to be 99.2% effective over three years when delivered via a single-handed inserter, compared to the 99.5% rate when delivered via a two-handed inserter.
Originally launched in partnership with Allergan, Liletta is the first product that Medicines360 has brought to market. The San Francisco-based nonprofit pharma company aims to expand women’s access to medicines in the U.S. and worldwide regardless of their socioeconomic status.