Balt Begin the STEM Trial: Receives IDE Approval From the FDA

May 15, 2020

Balt today announced they received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic Sub-Dural Hematoma. Chronic Sub-Dural Hematoma (cSDH) is a common disease affecting primarily older adults.

Balt notes a recent Veterans Affairs (VA) study of cSDH found a prevalence rate of 79.4 per 100,000 persons. The authors predicted that the incidence rate of cSDH in United States in the aging VA and civilian populations will reach 121.4 and 17.4 cases per 100,000 persons, respectively, by 2030, at which time, approximately 60,000 cases of chronic SDH will occur each year in 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,” stated Dr. David Fiorella.

The clinical trial is a prospective, randomized controlled 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 worked diligently to design a meaningful prospective, randomized, controlled, multi-center trial with the objective of demonstrating the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with the SQUID™ Liquid Embolic Device for the management of cSDH in both surgical and non-surgical patients. 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.”

Patients often present with focal neurological symptoms, non-focal cognitive symptoms 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.”


Reference

1Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in united states veterans administration and civilian populations. Journal of neurosurgery. 2015;123:1209-1215

SourceBALT USA

Hot this week

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution

Axlab, Danish Medtech Pioneer, expands to US with Advanced Robotic Tissue Sectioning for Pathology Laboratories

Kris Rokke, National Sales Director for Axlab in the US. "My team and I are extremely excited and honored about this unique opportunity to also offer this advanced technology to labs across the US and thus contribute to the pathology labs of tomorrow."

Spartan Medical Broadens Single-Use Sterile Instrument Portfolio to Improve Outcomes, Increase Efficiency, and Generate Cost Savings

Spartan Medical products portfolio of single-use, sterile med tech includes micro and minor surgical convenience kits, kerrison rongeurs, spinal and general surgical retractors, dural repair kits, synthetic biologics, and a wide range of orthopedic pre-sterilized implants and devices.

Recor Medical Supports European Society of Cardiology’s Hypertension Guidelines

Record Medical notes the new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.

ConTIPI Medical Selects EVERSANA to Support U.S. Commercialization of Non-Surgical Medical Device ProVate for Women with Pelvic Organ Prolapse

EVERSANA is a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse.