Texas Heart Institute doctors participating in clinical study of new device to ‘seal’ abdominal aortic aneurysms
Texas Heart Institute (THI) doctors at CHI St. Luke’s Health Baylor St. Luke’s Medical Center, are the first in Texas to have implanted a device designed to seal abdominal aortic aneurysms (AAAs), rather than bridging through the aneurysms using a traditional stent.
An aneurysm is a balloon-like bulge in an artery that, if left untreated, can rupture and cause serious complications or death. The abdominal aorta is the main artery carrying blood from the heart to the kidneys.
THI is among the centers chosen to participate in a clinical study to prove the safety and effectiveness of the Nellix Endovascular Aneurysm Sealing System, developed by the California-based Endologix, Inc. (www.endologix.com). The clinical study, called EVAS FORWARDIDE, will enroll 180 patients at 30 locations in the U.S., Europe, and Canada.
The Nellix sealing device, implanted through a catheter, has several potential advantages over stenting, explained Dr. Zvominir Krajcer, principal investigator for the study at THI. It can be used to treat a wider range of anatomies, it can eliminate endoleaks (blood flow within an aneurysm following stent repair), and is designed to minimize implant migration (shifting of the stent following treatment). The operating principle is centered around sealing the aneurysm sac with a polymer to prevent leaks and rupture.
“We are excited to participate in this trial and help advance treatment options for our patients,” added Dr. Neil Strickman, co-investigator for the trial who implanted the first device on March 11, 2014. “We also know that about 20 percent of stent patients need some sort of further treatment and we are hopeful that this device will eliminate that need.”
Aortic aneurysms are the primary cause of thousands of deaths each year in the United States and a contributing cause in thousands more deaths, according to the Centers for Disease Control and Prevention. The mortality rate is nearly 90 percent in patients whose aneurysms rupture. Studies have also shown that the prevalence of and risk factors for AAAs increase with age.
The Food and Drug Administration approved the U.S. clinical study in December 2013, following successful testing of the Nellix Endovascular Aneurysm Sealing device in Europe.