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MORGANTOWN – WVU Rockefeller Neuroscience Institute continues its mission to advance treatment of brain aneurysms with its participation in the clinical trial of a new device called SEAL.
SEAL stands for Saccular Endovascular Aneurysm Lattice, and manufacturer Galaxy Therapeutics calls their creation the SEAL Embolization System.
Dr. SoHyun Boo, medical director for Neurointerventional Surgery in RNI’s Department of Neuroradiology, explained the device and RNI’s participation in the trial, called SEAL-IT.
RNI treats minimally evasively through a catheter going inside the affected vessel, he said. “Traditionally, we use something called coils, which are usually platinum wires. That’s like 1990s technology. And since then, technology has continued to evolve with newer devices.”
Each evolution requires a new clinical trial. “So we’ve been doing clinical trials for new device technology, for example, for over 20 years.”
The SEAL device looks like a tiny wad of steel wool. A photo shows one next to a push pin and the SEAL is about the side of the pin’s head.
Galaxy calls it a dual braided flow diverting device and say its shape was inspired by the jellyfish.
Boo said the metal wires are braided together to form a mesh kind of plug.
“Aneurysm is a weakness in the wall of the blood vessel. And so that weakness in the wall starts to grow out into an aneurysm. And the blood flow through that opening, that neck of the aneurysm, is what we’re trying to cover or seal with the device. The braiding blocks the blood flow into the aneurysm.”
The SEAL comes in several sizes, and they size the plug to the size of the aneurysm, causing the aneurysm to occlude over time. Galaxy says occlusion can occur immediately, but within 24 hours.
The SEAL is placed via a catheter inserted through the groin or wrist, Boo said, guided by X-ray fluoroscopy.
RNI was invited to participate in the trial, he said, and Boo is the principal investigator for RNI’s portion of the trial. Nationally, the trail has enrolled about 70 patients across 30 medical centers so far and RNI leads the nation with the most enrollees – about 12.
Most trial patients were referred to RNI after presenting with incidental aneurysms, he said, meaning they had a head scan for some reason and the aneurysm was discovered in the scan.
“They get referred to us where we talk with the patient, get their history, understand if they have any other risk factors, and try to, you know, We counsel them on whether they should or should not get their aneurysm treated.” And if it needs treatment, they discuss the various options.
This is a trial to gain FDA approval for regular use, Boo said. “We’re testing for the efficacy of the device in terms of occluding the aneurysm, monitoring safety as far as not causing any untoward complications, any inherent higher risk than what we’ve currently been using that’s already been approved.”
AllClinicalTrials reports that the trial began in August 2024 and Galaxy anticipates a primary completion date of September 2026, with final completion date of September 2030. They expect to enroll 279 participants.
The trial evaluates the safety and effectiveness of the SEAL Embolization System in treating aneurysms up to 19 mm (about ¾ inch) in diameter. Data collection includes long-term outcomes at intervals of 24 hours, three months, six months, and 12 months post-procedure. Patients are then followed annually for up to five years.
