Womed, a uterine health company developing intrauterine treatments, today announced that the FDA havs approved the Pre-market Approval (PMA) application for the Womed Leaf for adult women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions, also referred to as Asherman syndrome.
The company said that Womed Leaf is the first medical device to be approved for sale in the U.S. for that indication.
Womed Leaf is intended to reduce the reoccurrence and severity of post-surgical adhesion formation inside the uterus. It consists of a soft thin film made from Womed's polymer, which is inserted like an IUD at the end of an adhesiolysis procedure. It expands within the cavity, preventing contact between the uterine walls, and is then naturally and painlessly discharged.
The pivotal PREG2 randomized clinical study that enrolled 160 patients with severe or moderate IUA demonstrated that Womed Leaf reduced the severity of intrauterine adhesion after hysteroscopic adhesiolysis compared with no prevention method and that Womed Leaf has an acceptable safety profile.
