Balt announced that it received FDA investigation device exemption (IDE) for its trial for the treatment of chronic sub-dural hematoma.
The Squid trial for the embolization of the middle meningeal artery (STEM) is a prospective, randomized controlled trial for Balt’s Squid liquid embolic device as a minimally invasive treatment option for the neurological disease.
Irvine, Calif.-based Balt will investigate the safety and effectiveness of middle meningeal artery (MMA) embolization with the Squid device for managing CSDH in both surgical and non-surgical patients.
Co-primary investigator Dr. Adam Arthur of the Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center said in a news release that the study will help to understand how to treat a major reversible cause of dementia and disability in the elderly.
“The approval of the IDE for the STEM trial represents a significant milestone for Balt as this will be our first prospective study in the United States and represents our commitment to investing in clinical trials that will deliver answers to currently unresolved clinical questions,” Balt CEO Pascal Girin said in the release.