Newly approved FDA device “rebuilds” diseased artery by diverting blood flow from aneurysm
STONY BROOK, N.Y., May 18, 2011 – Stony Brook University Medical Center is offering a revolutionary new treatment to
|Drs. David Fiorella (right) and Henry Woo of the Cerebrovascular Center (CVC) of the Department of Neurological Surgery at Stony Brook University Medical Center are offering a revolutionary new treatment to patients suffering from complex brain aneurysms.|
patients suffering from complex brain aneurysms. Recently approved by the Food and Drug Administration (FDA), the Pipeline Embolization Device (PED) is a stent-like device that enables physicians at the Cerebrovascular Center (CVC) of the Department of Neurological Surgery at Stony Brook to treat some of the most complex and dangerous brain aneurysms using minimally invasive techniques. Stony Brook’s CVC is one of a handful of centers in the U.S. that participated in initial FDA clinical trials of PED and is currently one of the only institutions nationwide with the ability to offer treatment with PED.
David Fiorella M.D., Ph.D., Professor of Clinical Neurological Surgery and Radiology at Stony Brook University School of Medicine, treated the first patients in North America with the device in 2007 and 2008 at the Cleveland Clinic when it was first approved for Phase III trial. Over the past four years, Dr. Fiorella has published numerous clinical research papers describing the application of the Pipeline Device to treat complex brain aneurysms. Dr. Fiorella and neurosurgeon Henry Woo, M.D., Associate Professor of Clinical Neurological Surgery and Radiology at Stony Brook University School of Medicine, also have been involved in the training and proctoring of physicians on the use of PED throughout the U.S. and worldwide.
“The Pipeline Embolization Device offers a unique and minimally invasive treatment option for some of the most difficult and complex brain aneurysms that we encounter,” says Dr. Fiorella. “Dr. Woo and I have gained a wealth of experience using the device within the context of the U.S. clinical trials and during our work teaching physicians around the world how to apply this novel technology.”
The PED is composed of multiple, fine, individual strands of platinum and cobalt chromium which are braided into a flexible, mesh tube. Once implanted across the neck of an aneurysm, the PED essentially rebuilds the diseased artery by diverting blood flow away from the aneurysm and along the course of the normal, reconstructed blood vessel. This treatment is an alternative to traditional open brain surgery or other endovascular techniques in which materials are placed within the aneurysm, such as coils or liquid embolic agents.
“Because reconstruction with PED is a minimally invasive procedure accomplished usually through a small femoral artery access site, it is frequently possible for patients to undergo the definitive treatment of a complex brain aneurysm and then leave the hospital the very next day – often returning to work just a few days afterward,” states Dr. Fiorella.
While previously only available within the context of clinical trials, the PED's recent FDA approval will allow Drs. Fiorella and Woo to treat the intended patient population according to standard clinical care guidelines.
For more information on treating brain aneurysm patients and treatment options available at the Cerebrovascular Center at Stony Brook University Medical Center, please call 631-444-2772.
Drs. David Fiorella (right) and Henry Woo of the Cerebrovascular Center (CVC) of the Department of Neurological Surgery at Stony Brook University Medical Center are offering a revolutionary new treatment to patients suffering from complex brain aneurysms.
About the Cerebrovascular Center at Stony Brook University Medical Center
The Cerebrovascular Center (CVC) at Stony Brook University Medical Center has a dedicated team of physicians, nurses, physician assistants and radiology technologists with the expertise needed to diagnose and treat the complete range of cerebrovascular diseases including arteriovenous malformations, arteriovenous fistulas, hemorrhagic strokes, ischemic strokes, atherosclerosis, and carotid stenosis. The multidisciplinary team of neurologists, interventional neuroradiologists, neuro-anestesiologists and neurosurgeons are committed to excellence in patient care, research, and education.
The CVC is home to an active clinical trials unit supported by three clinical research coordinators and a National Institutes of Health funded engineering and tissue laboratory. The Center enrolls patients or participates in virtually all of the major trials that are currently underway in the U.S. As a result, patients have access to a wide variety of experimental devices that are available only through a research trial or on a "compassionate use" basis to patients who have otherwise untreatable conditions.
In addition to the multidisciplinary expertise of the clinical team and the vast array of treatment techniques and devices, the CVC includes multi-million dollar state-of-the-art bi-plane angiography suites, and high speed computed tomography (CT) and magnetic resonance imaging (MRI) facilities.