Materna’s device successfully prevents first-time mothers from pelvic floor injury.

Materna Medical has showcased positive results from its pelvic floor dilator designed to reduce muscle injury during first-time vaginal deliveries. Published in the *International Urogynecology Journal*, the study indicates the device significantly lowers the risk of levator ani muscle avulsion.

Materna is now recruiting for a pivotal trial to support FDA marketing approval. The levator ani muscle, essential to the pelvic floor, is prone to avulsion, causing severe issues like sexual, urinary, or fecal dysfunction in about 15% of cases.

The Materna Prep device, inserted during labor, gently stretches the vagina and surrounding muscles. In the EASE trial with 214 first-time mothers, none of the 46 women using the device had levator ani avulsion, compared to a 10.9% rate in the control group. There was one serious adverse event linked to the device, but no serious neonatal issues. Materna also offers Milli, an FDA-cleared device for vaginismus, currently under a post-market study.