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

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.”

About Balt:

Since it was established in 1977, Balt has worked with interventional physicians to develop devices to treat complex life-threatening neurovascular conditions such as ischemic strokes, aneurysms and arteriovenous malformations. A pioneer in the neurovascular field, Balt designs, manufactures and distributes the broadest portfolio of products in the neurovascular space and is now focused on expanding its geographic presence in both the USA and China. Visit Balt at https://www.balt-corp.com/.

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

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