BOSTON, MA — February 4, 2026 — Leads & Copy — Balt, Inc., has received Premarket Approval (PMA) from the FDA for its Squid™ liquid embolic agent, the company announced today. Squid is now approved for embolization of the middle meningeal artery (MMA) as an adjunct to usual care for patients with large symptomatic chronic subdural hematoma(s) (cSDH).
Chronic subdural hematomas are a common type of intracranial hematoma, particularly in older adults. The condition presents significant morbidity and mortality risks, with incidence rising due to population aging and increased use of anticoagulant and antiplatelet therapies.
The approval follows positive results from The Squid Trial for the Embolization of the Middle meningeal artery (STEM), the first prospective, randomized study assessing embolization’s impact on treatment failures within this patient population. The study, published in the New England Journal of Medicine in November 2024, demonstrated that adjunctive embolization of the MMA with Squid significantly reduced treatment failure rates without increasing adverse events in patients managed with surgery or medical management.
Dr. David Fiorella, STEM Trial Principal Investigator (Stony Brook University Medical Center), stated that middle meningeal artery embolization showed promise for these patients. He also said that 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. Dr. Fiorella expressed gratitude for Balt’s leadership team’s support of STEM, and acknowledged the STEM investigators and the patients who participated in the trial. He said that together, they 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, an EVOH based device, offers a wide range of viscosities (12, 18 and 34) and micronized tantalum.
Balt CEO Pascal Girin said that the company has obtained its first PMA approval for one of its technologies. Girin noted this marks a major milestone for Balt’s growth and for advancing care for patients with cSDH. Girin also acknowledged principal investigators Dr. Arthur and Dr. Fiorella and all the STEM investigators, and mentioned that this has opened an important area for additional research. Balt will continue to be a leader on this front, he said.
The Squid liquid embolic agent was originally approved for use in Europe in 2012. The agent is an ethyl vinyl alcohol (EVOH) copolymer in a dimethyl sulfoxide (DMSO) solvent used in embolization of blood vessels in vascular diseases. Approved by the FDA in 2026, Squid is indicated for embolization of the middle meningeal artery (MMA) as an adjunct to usual care in patients with symptomatic chronic subdural hematoma(s) (SDH) measuring 10 mm or greater in thickness.
Balt, established in 1977, develops devices to treat complex life-threatening neurovascular conditions. Balt designs, manufactures, and distributes a portfolio of products in the neurovascular space and has experienced rapid global development, particularly in the United States.
Source: Balt, Inc.
