UofL Physicians – Neurosurgery, part of UofL Health – Brain & Spine Institute, is the first in Kentucky to be accepted into the next phase of a multicenter FDA study evaluating an alternative treatment option for patients with brain aneurysms.
Brain aneurysms result from a weakened area in an artery of the brain that fills with blood and causes outward bulging or ballooning.
The Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial (SEAL™ IT) focuses on the safety and effectiveness of the SEAL system, which can be used to treat patients with ruptured and unruptured brain aneurysms in a range of sizes.
SEAL IT Device Base
SEAL IT Device Arc
“I’m excited to be a part of groundbreaking aneurysm treatment research, and for the opportunity to bring patients in Louisville and the surrounding region a novel treatment option not yet widely available,” said Josh Abecassis, M.D., a neurosurgeon with Brain & Spine Institute. “The device is small enough that we can use a minimally invasive technique via an artery in the groin to deliver the device and disrupt the blood flow to the aneurysm, causing it to clot and heal, while decreasing the need for more invasive procedures like a craniotomy.”
Patients with brain aneurysms are usually asymptomatic until their aneurysm ruptures. A ruptured aneurysm is a form of stroke and a potentially life-threatening condition that can result in brain damage or death.
“As an academic health care system affiliated with the University of Louisville, we are committed to providing our patients with the latest innovative treatments, including those offered through clinical trials,” said Joshua Beardsley, system vice president of neurosciences and spine. “I’m proud of our providers for helping to pioneer the next generation of aneurysm care.”
About SEAL™ IT
SEAL™ IT is a prospective, U.S. and international single-arm, multicenter, interventional study. The clinical trial seeks to establish the safety and effectiveness of the system in treating patients with wide neck unruptured or ruptured intracranial aneurysms that are less than or equal to 19 millimeters in widest diameter. Data such as imaging and patient presentation will be collected from participants immediately after their procedure in addition to three, six and 12 months after their procedure. Participants will receive follow-ups annually for five years.
