Balt receives IDE approval to begin the STEM trial

2017

Squid trial embolisation baltBalt has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the Squid trial for the embolisation of the middle meningeal artery (STEM) for the treatment of chronic subdural haematoma.

A recent Veterans Affairs (VA) study of chronic subdural haematoma found a prevalence rate of 79.4 per 100,000 persons. The authors predicted that the incidence rate of chronic subdural haematoma in USA in the aging VA and civilian populations will reach 121.4 and 17.4 cases per 100,000 persons, respectively, by 2030. By this time, approximately 60,000 cases will occur each year in the USA.

“We are excited to have the opportunity to investigate the Squid Liquid Embolic Device as a minimally invasive treatment option for this common and disabling neurological disease,” stated David Fiorella in the company’s news release.

Co-primary Investigators Adam Arthur (Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center) and David Fiorella (Stony Brook University Medical Center) have worked to design a prospective, randomised, controlled, multicentre trial with the objective of demonstrating the safety and effectiveness of middle meningeal artery (MMA) embolisation with the SQUID Liquid Embolic Device for the management of chronic subdural haematoma in both surgical and non-surgical patients.

Arthur commented, “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 intensive care unit.”

Patients often present with focal neurological symptoms, non-focal cognitive symptoms or generalised dysfunction. “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,” added Arthur.

Fiorella went on to state, “We have seen some dramatic radiological and clinical improvement using liquid embolic agents to treat patients with chronic subdural haematoma, both as an adjunct to surgical treatment and as a stand-alone therapy. We are hopeful that this randomised controlled trial will provide definitive evidence that embolisation of the middle meningeal artery with Squid will not only improve surgical outcomes but will also provide a minimally invasive endovascular treatment option for patients who do not require urgent or emergent open cranial surgery. Improving outcomes for this large group of patients would represent a significant advance.”


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