Balt has announced the US Food and Drug Administration (FDA) premarket approval (PMA) of its Squid liquid embolic agent, meaning Squid can be used for embolisation of the middle meningeal artery (MMA) as an adjunct to standard treatment in patients with large symptomatic chronic subdural haematomas (cSDHs).
The approval comes following results from the STEM trial—described by Balt as the first prospective, randomised study assessing the impact of embolisation on treatment failures in this large patient population. The study—from which findings were published in the New England Journal of Medicine in November 2024—demonstrated that adjunctive MMA embolisation with Squid significantly reduced treatment failure rates without increasing adverse events in patients receiving either surgery or medical management.
“CSDH is a common disease, and existing management strategies—both surgical and non-surgical—have been traditionally associated with high rates of failure,” commented STEM trial co-principal investigator David Fiorella (Stony Brook University Medical Center, Stony Brook, USA). “It was clear from the initial cases that Adam Arthur [University of Tennessee Health Science Center, Memphis, USA] and I performed that MMA embolisation 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, randomised 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.”
According to Balt, the Squid liquid embolic agent is an ethylene-vinyl alcohol (EVOH)-based device that provides the “unique advantages” of a wide range of viscosities—12, 18 and 34—and micronised tantalum.
“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,” said Balt chief executive officer (CEO) Pascal Girin. “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.”
