Saturday, May 04, 2024
OrthoPediatrics has achieved a significant milestone with the FDA granting its eLLi surgical device the "Breakthrough Device" Designation.
This innovative implant is designed to address severe pathology associated with Early Onset Scoliosis (EOS), a condition that can be life-threatening due to thoracic insufficiency.
ELLi offers a non-invasive means of extending growing rods, providing increased force, reliability, and precision in distraction, while also addressing safety concerns linked with current technology.
The Breakthrough Devices Program by the FDA expedites the development and review process for devices targeting life-threatening or debilitating conditions, ensuring timely access while maintaining regulatory standards
Source: globenewswire.com
