IRVINE, Calif.–(BUSINESS WIRE)–May 15, 2020–
Balt introduced at the moment it has acquired Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to start The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the remedy of persistent Sub-Dural Hematoma. Chronic Sub-Dural Hematoma (cSDH) is a typical illness affecting primarily older adults. A current Veterans Affairs (VA) examine of cSDH discovered a prevalence fee of 79.four per 100,000 individuals. The authors predicted that the incidence fee of cSDH in United States within the ageing VA and civilian populations will attain 121.four and 17.four instances per 100,000 individuals, respectively, by 2030, at which period, roughly 60,000 instances of persistent SDH will happen every year within the United States.1 “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,” said Dr. David Fiorella.
The scientific trial is a potential, randomized managed trial.
Co-Primary Investigators Dr. Adam Arthur (Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center) and Dr. David Fiorella (Stony Brook University Medical Center) have labored diligently to design a significant potential, randomized, managed, multi-center trial with the target of demonstrating the security and effectiveness of Middle Meningeal Artery (MMA) embolization with the SQUID™ Liquid Embolic Device for the administration of cSDH in each surgical and non-surgical sufferers. Dr. Arthur mentioned, “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.”
Patients usually current with focal neurological signs, non-focal cognitive signs or generalized 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 Dr. Arthur.
Dr. Fiorella went on to state, “We have seen some dramatic radiological and clinical improvement using liquid embolic agents to treat patients with cSDH, both as an adjunct to surgical treatment and as a stand-alone therapy. We are hopeful that this randomized controlled trial will provide definitive evidence that embolization 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.”
Balt CEO Pascal Girin commented, “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.”
Since it was established in 1977, Balt has labored with interventional physicians to develop gadgets to deal with complicated life-threatening neurovascular situations akin to ischemic strokes, aneurysms and arteriovenous malformations. A pioneer within the neurovascular discipline, Balt designs, manufactures and distributes the broadest portfolio of merchandise within the neurovascular house and is now targeted on increasing its geographic presence in each the USA and China. Visit Balt at https://www.balt-corp.com/.
1Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence charges for persistent subdural hematomas in u.s. veterans administration and civilian populations. Journal of neurosurgery. 2015;123:1209-1215
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