Texas Heart Institute Doctors Participating in Clinical Study of New Device to 'Seal' Abdominal Aortic Aneurysms
(Houston - March 13, 2014) Texas
Heart Institute 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.
Texas
Heart Institute 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 FORWARD-IDE,
will enroll 180 patients at 30 locations in the United States, Europe,
and Canada.
Dr. Zvonimir Krajcer
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The Nellix sealing device, implanted through a
catheter, has several potential advantages over stenting, explained
Dr.
Zvonimir Krajcer, principal investigator for the study at Texas Heart
Institute. 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 his 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. For more
information about about abdominal aortic aneurysms, see www.texasheart.org/HIC/Topics/Cond/Aneurysm.cfm.
For media inquiries please contact:
Director of Public Affairs
Texas Heart Institute
Frank Michel ♦ 832-355-9510 ♦ fmichel@texasheart.org
For THI media profile, see Public Affairs.
