BOSTON, Feb. 09, 2024 (GLOBE NEWSWIRE) -- Balt, Inc., a global technology leader in neurovascular devices, today announced the presentation of preliminary data from The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic Sub-Dural Hematoma during the late-breaking session at the International Stroke Conference in Phoenix, AZ. The preliminary data demonstrates that rates of complications thus far are low and embolizing the MMA for the treatment of Chronic Subdural Hematoma (cSDH) potentially improves the success rates of both surgical and non-surgical treatments.
Co-Principal Investigator Adam Arthur, MD, MPH presented six-month follow-up data on the 310 subjects from the prospective, multi-center, multi-national randomized trial comparing patients who received embolization of the middle meningeal artery (MMA) with Squid™ Liquid Embolic as an adjunct to standard management against those who did not. Standard management included surgical drainage of the subdural hemorrhage for qualified patients and best medical management for patients who did not require surgery. STEM, which completed enrollment last year, is the first prospective IDE trial investigating embolization of the MMA for the treatment of chronic Sub-Dural Hematoma (cSDH).
Dr. Arthur, (Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center) further commented, “cSDH is a treatable cause of disability and death for many older patients, and this trial is a major step forward in improving treatment for these patients.”
Balt CEO Pascal Girin commented, “I am very proud that we at Balt were the first company to initiate and complete enrollment in a prospective, randomized controlled trial in this important disease state that impacts many patients worldwide. The preliminary data are encouraging, and we look forward to submitting the full data set to the FDA later this year with the aim of bringing our technology to the US for physicians to treat this prominent disease.”
Chronic Subdural Hematoma is a common disease affecting primarily older adults. A 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 the 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
“The international team of investigators and participating patients have done fantastic work to study the importance of this therapy,” said Co-Principal Investigator David Fiorella, MD, PhD (Stony Brook University Medical Center).
About Squid Liquid Embolic:
Squid Liquid Embolic is an Investigational device. Limited by Federal (or United States) law to investigational use.
About Balt:
Since it was established in 1977, Balt has been a pioneering innovator in the neurovascular field working closely with interventional physicians to develop devices to treat complex life-threatening neurovascular conditions such as ischemic strokes, aneurysms, dural fistulas, arteriovenous malformations and a variety of other conditions. A pioneer in the neurovascular field, Balt designs, manufactures and distributes the broadest portfolio of products in the neurovascular space. Visit Balt at https://www.baltgroup.com/
Contact
Greg Chodaczek
Gilmartin Group
greg@gilmartinir.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
