May 14, 2020
STEM Trial Approved for Balt’s Squid Liquid Embolic Device
May 14, 2020—Balt announced investigational device exemption (IDE) approval from the FDA to begin STEM, the Squid trial for the embolization of the middle meningeal artery (MMA) to treat chronic subdural hematoma (cSDH).
According to Balt, STEM is a prospective, randomized controlled multicenter trial of the company's Squid liquid embolic device. The trial's objective is demonstrating the safety and effectiveness MMA embolization with the Squid device for the management of cSDH in both surgical and nonsurgical patients. The study's coprimary investigators are Adam Arthur, MD, and David Fiorella, MD.
“This is a disease which affects a large number of people, and preys particularly on the elderly. Current treatment options are not well-studied and often require invasive surgeries and prolonged stays in the intensive care unit,” stated Dr. Arthur in the company's announcement, which noted that patients often present with focal neurological symptoms, nonfocal cognitive symptoms, or generalized dysfunction. Dr. Arthur continued, “The STEM study will enable us to learn a tremendous amount about how to help these patients and how best to treat a major reversible cause of dementia and disability in the elderly.”
Dr. Fiorella commented, “We are excited to have the opportunity to investigate the Squid liquid embolic device as a minimally invasive treatment option for this common and disabling neurological disease. We have seen some dramatic radiological and clinical improvement using liquid embolic agents to treat patients with cSDH, both as an adjunct to surgical treatment and as a stand-alone therapy.”
He concluded, “We are hopeful that this randomized controlled trial will provide definitive evidence that embolization of the middle meningeal artery with Squid will not only improve surgical outcomes but will also provide a minimally invasive endovascular treatment option for patients who do not require urgent or emergent open cranial surgery. Improving outcomes for this large group of patients would represent a significant advance.”