Materna Medical Reports Enrolment Completion in EASE Trial of Ellora System to Reduce Pelvic Injury from Vaginal Delivery
Shots:
- Materna Medical has completed enrolment in its EASE trial of Ellora Obstetrical System (formerly Materna Prep device) for first-time mothers
- Trial will evaluate safety & effectiveness of the Ellora System vs SoC in 420 first-time mothers for the reduction of pelvic muscle injury during vaginal delivery; EASE trial will support the upcoming US FDA’s filing
- Ellora Obstetrical System features an expanding vaginal dilator to help withstand childbirth strain & reduce LAM injury risk, with P-II (EASE) trial data published in The International Urogynecology Journal
Ref: Businesswire | Image: Materna Medical | Press Release
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