Med-Tech Advance for 'Silent
Killer': FDA Approves Medtronic Device to Fix Abdominal Aortic
Aneurysms
Endurant® AAA Stent Graft Expands Patient Access to Minimally Invasive Procedure to Repair Dangerous Bulge in Body’s
Main Artery Without Major Surgery
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Endurant® AAA
Stent Graft
System from Medtronic, Inc. |
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December
21, 2010 -- Minneapolis -- An estimated 1.2 million
people in the United States have an abdominal aortic aneurysm
(AAA) – a dangerous
bulge or ballooning in their bodies’ main artery1 that typically
causes no symptoms until it ruptures, which can be deadly – and
most of them don’t know it.
But for those with a known AAA of
a certain size, there’s a new medical device for a safe and effective
treatment option that doesn’t require major surgery, an extended
hospital stay and a long recovery period. |
The U.S. Food and Drug Administration (FDA)
today approved the Endurant® AAA Stent Graft System from Medtronic,
Inc. (NYSE: MDT) for the minimally invasive treatment of this largely
unknown, and often fatal, condition. The
Endurant stent graft is a flexible wire frame (stent) sewn
onto a specially woven fabric tube (graft) that physicians
use to create a new path for blood flow in the patient’s aorta,
reducing pressure on the aneurysm and the risk of rupture.
Delivered through catheters inserted into blood vessels in
the groin, the new device is designed to conform to a broad
range of aortic anatomies, enabling physicians to offer endovascular
aortic repair (EVAR) to more AAA patients than ever before. “With FDA approval of Medtronic’s Endurant stent graft, U.S. physicians now have access to a new-generation device that will allow safe treatment of even more complex AAA patients with EVAR than was feasible with previous devices,” said Dr. Michel Makaroun, M.D., professor and chief of vascular surgery at the University of Pittsburgh Medical Center, and the principal investigator for the U.S. clinical study. “With
its innovative design and delivery system, the Endurant
stent graft represents another significant advance that
expands our toolkit for the minimally invasive management
of this dangerous, often deadly, condition.”
In the study, which supported the device’s FDA approval, there were no post-implant aneurysm ruptures or aneurysm-related deaths through one year of patient follow-up, and no patients experienced enlargement of their aneurysms (all remained stable or shrank in size) during this timeframe. Also through one year, there were no device migrations or device-related “endoleaks,” which
can result in persistent blood flow into the aneurysm sac and enlargement
of the aneurysm. The study involved 150 patients and 26 medical
centers, and successfully met its primary goals and endpoints for
assessing the safety and effectiveness of the Endurant stent graft. Undetected or untreated, AAAs can burst unexpectedly with often fatal consequences, making this condition the third leading cause of sudden death in men over age 60.2 Approximately
75–90 percent of undiagnosed AAA patients will die if – or when – their
aneurysm ruptures3, designating the condition a “silent
killer.”
AAAs rarely cause symptoms until they rupture, which usually results in death due to rapid and extensive internal bleeding. They are often found coincidentally on X-rays or other medical imaging studies performed for other reasons. Detection and diagnosis of this condition are critical to its effective management. The Society for Vascular Surgery recommends treatment for AAAs that are 5.5 cm or greater in diameter. Physicians
rely primarily on two approaches to treat AAAs: open surgical
repair and endovascular repair. Open surgical repair requires
a large incision in the abdomen to access the aorta; it
involves removal of the aneurysmal segment and replacement
with a synthetic graft that is sewn onto healthy aortic
tissue. Endovascular repair is a less invasive procedure
in which a stent graft – a wire mesh (stent) supporting a fabric tube (graft) – is compressed on a delivery catheter, threaded through an artery in the groin and expanded at the site of the aneurysm; it does not require removal of the aneurysmal segment. EVAR has emerged over the last decade as a viable alternative to open surgery because it significantly reduces the patient’s
hospital stay and recovery period. “Offering great therapeutic solutions to the highly skilled clinicians who treat patients with aortic disease is the foundation of our leadership in EVAR,” said Tony Semedo, vice president and general manager of Medtronic’s Endovascular Innovations business. “In
addition to a portfolio of market-leading stent grafts,
Medtronic offers a suite of ancillary products and
support services that spans the continuum of care for
patients with aortic disease. Our leadership also extends
to advocacy for screening, diagnosis and management
of this highly treatable condition.” Medtronic is committed to advancing the treatment of cardiovascular disease through collaboration with leading clinicians, researchers and scientists worldwide.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com),
headquartered in Minneapolis, is the global leader in medical technology – alleviating
pain, restoring health and extending life for millions of people
around the world.
Any
forward-looking statements are subject to risks and uncertainties
such as those described in Medtronic’s periodic reports on file with
the Securities and Exchange Commission. Actual results may differ
materially from anticipated results.
1 Society for Vascular Surgery. Protect Yourself From An AAA Rupture. http://www.vascularweb.org/patients/ prevention/aaa_rupture.html. Accessed August 3, 2009.
2 Ohki T, Veith FJ. Endovascular Repair of Ruptured,
AAAs In treating AAAs, endovascular repair may hold the key over
open repair to lowering mortality. Endovascular Today.
January 2004;47-51.
3 Earnst, CB Abdominal Aortic Aneurysm. N Engl J Med.1993;328:1167-72.
Source: Medtronic,
Inc.
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