The WVU Rockefeller Neuroscience Institute (RNI) has emerged as the leading center in a groundbreaking clinical trial investigating a novel brain aneurysm treatment device called the SEAL Embolization System. The innovative technology, developed by Galaxy Therapeutics, represents a significant advancement over traditional platinum coil treatments that have been in use since the 1990s.
Dr. SoHyun Boo, medical director for Neurointerventional Surgery in RNI's Department of Neuroradiology and principal investigator for the study at WVU, explains that the SEAL (Saccular Endovascular Aneurysm Lattice) device employs a unique dual-braided mesh design inspired by jellyfish. The device, approximately the size of a pushpin head, is specifically engineered to address the challenges of treating brain aneurysms.
Advanced Technology and Mechanism of Action
The SEAL device functions by targeting the fundamental problem of aneurysms - weaknesses in blood vessel walls that result in abnormal bulging. "The braiding blocks the blood flow into the aneurysm," Dr. Boo explains. The mesh plug is precisely sized to match individual aneurysm dimensions, promoting rapid occlusion that can occur within 24 hours of placement.
Minimally Invasive Procedure
The treatment procedure involves delivering the SEAL device through a catheter inserted via the groin or wrist, guided by X-ray fluoroscopy. This minimally invasive approach aligns with modern neurosurgical preferences for reducing patient trauma and recovery time.
Clinical Trial Progress and Scope
The SEAL-IT trial, which commenced in August 2024, has already enrolled approximately 70 patients across 30 medical centers nationwide. WVU RNI leads enrollment numbers with about 12 participants, demonstrating the institution's commitment to advancing neurosurgical treatments.
Patient Selection and Monitoring
Most trial participants were identified through incidental findings during routine head scans. The study focuses on treating aneurysms up to 19 mm in diameter, with comprehensive follow-up protocols extending to five years post-procedure. Patients undergo evaluations at key intervals: 24 hours, three months, six months, and 12 months after the procedure, followed by annual assessments.
Trial Objectives and Timeline
The primary goal of this FDA approval trial is to evaluate both the efficacy of the SEAL device in achieving aneurysm occlusion and its safety profile compared to currently approved treatments. Galaxy Therapeutics anticipates primary completion by September 2026, with final completion scheduled for September 2030, aiming to enroll a total of 279 participants.
The trial represents a significant step forward in the evolution of neurovascular treatments, potentially offering patients a more advanced alternative to traditional aneurysm management methods.
