Balt Begin the STEM Trial: Receives IDE Approval From the FDA

May 15, 2020

Balt today announced they received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic Sub-Dural Hematoma. Chronic Sub-Dural Hematoma (cSDH) is a common disease affecting primarily older adults.

Balt notes a recent Veterans Affairs (VA) study of cSDH found a prevalence rate of 79.4 per 100,000 persons. The authors predicted that the incidence rate of cSDH in United States in the aging VA and civilian populations will reach 121.4 and 17.4 cases per 100,000 persons, respectively, by 2030, at which time, approximately 60,000 cases of chronic SDH will occur each year in the United States.¹ “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,” stated Dr. David Fiorella.

The clinical trial is a prospective, randomized controlled trial.

Co-Primary Investigators Dr. Adam Arthur (Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center) and Dr. David Fiorella (Stony Brook University Medical Center) have worked diligently to design a meaningful prospective, randomized, controlled, multi-center trial with the objective of demonstrating the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with the SQUID™ Liquid Embolic Device for the management of cSDH in both surgical and non-surgical patients. Dr. Arthur said, “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 ICU.”

Patients often present with focal neurological symptoms, non-focal cognitive symptoms or generalized dysfunction. “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,” added Dr. Arthur.

Dr. Fiorella went on to state, “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. 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.”

Balt CEO Pascal Girin commented, “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.”

Reference

¹Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in united states veterans administration and civilian populations. Journal of neurosurgery. 2015;123:1209-1215