BOSTON, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Balt, Inc., a global technology leader in neurovascular devices, today announced the Premarket Approval (PMA) of the Squid liquid embolic agent. Squid is approved for the embolization of the middle meningeal artery (MMA) as an adjunct to usual care treatment in patients with large symptomatic chronic subdural hematoma(s) (cSDH).
Chronic subdural hematomas are a common type of intracranial hematoma in older adults. They are a significant source of morbidity and mortality, with an incidence that is increasing due to population aging and the widespread use of anticoagulant and antiplatelet therapies.
The approval comes following the results from The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic Sub-Dural Hematoma study, the first prospective, randomized study assessing the impact of embolization on treatment failures in this large patient population. The study, published in the New England Journal of Medicine in November of 2024, demonstrated that adjunctive embolization of the MMA with Squid significantly reduced treatment failure rates without increasing adverse events in patients managed with either surgery or medical management.
STEM Trial Principal Investigator David Fiorella, MD, PhD (Stony Brook University Medical Center) commented that "Chronic subdural hematoma is a common disease, and existing management strategies (both surgical and non-surgical) have been traditionally associated with high rates of failure. It was clear from the initial cases that Dr. Adam Arthur and I performed that middle meningeal artery embolization showed promise for these patients. However, high quality data were required to confirm the effectiveness and safety of the procedure and to ultimately generate a paradigm shift towards this minimally invasive treatment becoming the standard of care. I am very thankful that Balt's leadership team aligned with this vision and took the bold step to support STEM, the very first prospective randomized trial assessing the effect of liquid embolics in patients with symptomatic cSDH. Together, along with all the STEM investigators and the patients who participated in this trial, we have moved the neurointerventional field forward with this new indication, provided the US market access to a new tool in Squid, and improved the care for patients."
The Squid liquid embolic agent is an EVOH based device that provides the unique advantages of a wide range of viscosities (12, 18 and 34) and micronized tantalum.
Pascal Girin, CEO of Balt, commented, "In the near 50-year history of Balt, I am proud to say that we have obtained our first PMA approval for one of our technologies. This marks a major milestone not only for the growth of Balt, but also for the advancement in care of patients suffering from cSDH. The entire Balt team is incredibly grateful to our principal investigators, Dr. Arthur and Dr. Fiorella, who collaborated with us to drive the shift we see in clinical practice today and to all the STEM investigators who helped complete the necessary trial to obtain this approval. I am also excited that this has opened an important area for additional research to better understand treatments for this disease. Balt will continue to be a leader on this front."
About Squid Liquid Embolic Agent:
Originally approved for use in Europe in 2012, the Squid liquid embolic agent is an ethyl vinyl alcohol (EVOH) copolymer in a dimethyl sulfoxide (DMSO) solvent used in embolization of blood vessels in vascular diseases. Squid has been approved for use by the FDA in 2026 and is indicated for the embolization of the middle meningeal artery (MMA) as an adjunct to usual care treatment in patients with symptomatic chronic subdural hematoma(s) (SDH) measuring 10 mm or greater in thickness in whom an intervention is deemed necessary as determined by a neurosurgeon.
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, chronic subdural hematomas, dural fistulas, arteriovenous malformations and a variety of other conditions. Balt designs, manufactures and distributes the broadest portfolio of products in the neurovascular space. In recent years, the company has experienced rapid acceleration in its global development, particularly in the United States.
For more information, please visit www.baltgroup.com.
Contact
Greg Chodaczek
Gilmartin Group
greg@gilmartinir.com
