US FDA grants IDE approval to Balt to begin STEM trial

15 May 2020 (Last Updated May 15th, 2020 09:54)

Balt has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic subdural hematoma (cSDH).

US FDA grants IDE approval to Balt to begin STEM trial
Chronic sudural hematoma is a common disease primarily seen in older adults. Credit: Nephron.

Balt has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic subdural hematoma (cSDH).

The trial will evaluate the safety and effectiveness of the middle meningeal artery (MMA) embolisation with the Squid liquid embolic device for the management of cSDH in both surgical and non-surgical patients.

Balt CEO Pascal Girin said: “The approval of the IDE for the STEM trial represents a significant milestone for Balt as this will be our first prospective study in the United States and represents our commitment to investing in clinical trials that will deliver answers to currently unresolved clinical questions.”

cSDH is a common disease primarily seen in older adults. According to a recent Veterans Affairs (VA) study, cSDH has a prevalence rate of 79.4 per 100,000 people.

By 2030, the incidence rate of the disease in the US in the ageing VA and civilian populations is expected to reach 121.4 and 17.4 cases respectively.

Dr Adam Arthur and Dr David Fiorella are the co-primary investigators of the prospective, randomised and controlled multi-centre clinical trial.

Dr Arthur said: “This is a disease, which affects a large number of people, and preys particularly on the elderly. Current treatment options are not well-studied and often require invasive surgeries and prolonged stays in the ICU.

“The STEM study will enable us to learn a tremendous amount about how to help these patients and how best to treat a major reversible cause of dementia and disability in the elderly.”