BOSTON, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Balt, Inc., a global technology leader in neurovascular devices, today announced the publication of The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic Sub-Dural Hematoma in the New England Journal of Medicine. The study shows that among patients with symptomatic chronic subdural hematoma (cSDH), adjunctive middle meningeal artery (MMA) embolization resulted in a lower risk of treatment failure than standard treatment alone, without resulting in an increased incidence of disabling stroke or death in the short term. STEM is the first randomized prospective IDE trial investigating embolization of the MMA for the treatment of cSDH.

Co-Principal Investigator David Fiorella, MD, PhD (Stony Brook University Medical Center) commented, “This pivotal trial provides critical information to guide how we are treating our cSDH patients.” He continued, “STEM results show that the addition of MMA embolization to either surgical or medical management reduces the incidence of recurrence or additional procedures, which is critical for this largely geriatric patient population.”

The STEM trial is a prospective, multi-center, international randomized controlled trial enrolling 310 patients comparing those who received embolization of the MMA with SQUID™ Liquid Embolic as an adjunct to standard surgical or medical management against those who did not. The addition of embolization showed a significant reduction in treatment failures: 36% of the standard management group compared to only 16% in the embolization group. Furthermore, the embolization procedures did not increase major adverse events or deaths.

Co-Principal Investigator Adam Arthur, MD, MPH, (Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center) added, “Embolization of the MMA has rapidly evolved towards becoming the standard of care for patients suffering with cSDH. These data confirm that the paradigm shift we have been seeing in clinical practice over the last few years is the most appropriate approach for these patients and can reduce treatment failures with this challenging disease state.”  

Balt CEO Pascal Girin commented, “The publication of the STEM trial in the New England Journal of Medicine highlights the importance of this prospective trial for this patient population. We are very proud to have sponsored the STEM study and look forward to continuing to invest in clinical research to advance the care of neurovascular patients and to bring the innovative Balt portfolio of products to market”.

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 cSDH will occur each year in the United States.¹

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