A new device that reduces and redirects blood flow away from a bulge in the wall of a blood vessel in the brain known as an aneurysm is being tested in patients at Roosevelt Hospital in a clinical trial that could bring new hope to patients with hard-to-treat aneurysms.
The dual-layer flow diversion stent, known as the FRED™ System, is a small, metallic mesh tube that is inserted into the blood vessel across the entrance to the aneurysm. It contains the flow of blood within the tube to keep it away from the aneurysm, causing the aneurysm to clot and minimizing the chance of rupture.
Roosevelt Hospital is the only site in New York City offering the treatment, and its principal investigator is Johanna Fifi, MD, Director of Endovascular Stroke at the Hyman-Newman Institute for Neurology and Neurosurgery. Dr. Fifi says the FRED™ device “was designed to treat aneurysms that were previously thought to be untouchable. It can be partially deployed, retrieved, and accurately repositioned or redeployed to ensure the most precise placement, which we expect will result in improved outcomes for our patients.”
The trial’s co-investigators are Alejandro Berenstein, MD, Director of the Hyman-Newman Institute for Neurology and Neurosurgery, and Srinivasan Paramasivam, MD, Attending Physician at the Hyman-Newman Institute.
MicroVention Inc., maker of the device, and sponsor of the 25-center, prospective, pivotal U.S. clinical trial, also manufactures a coil system to treat cerebral aneurysms. The new device, however, is targeted at patients whose aneurysms are large or oddly shaped, and particularly difficult to reach.
During the procedure, the physician positions a microcatheter across the entrance of the aneurysm. When the microcatheter is in place, the device is deployed across the entrance and expands to fit the wall of the artery. The microcatheter is then removed.
An estimated 6 million people in the United States have an unruptured brain aneurysm. As an aneurysm grows, the vessel wall becomes thinner and can weaken to the point of rupturing, causing bleeding around the brain. This situation can be fatal and requires immediate treatment.