FREMONT, Calif., Nov. 19, 2015 /PRNewswire/ -- Cordis Corp. today
announced the presentation of four-year data from its INNOVATION
Trial at the 2015 VEITHsymposium® in New York City. Data from the study continues
to demonstrate the INCRAFT® AAA Stent Graft System
(INCRAFT® System) performs well in patients suffering
from abdominal aortic aneurysms (AAA) four years after
treatment.
The INNOVATION Trial is a multicenter, open-label, prospective
study designed to assess the safety and performance of the device
in the treatment of patients with AAA with investigational sites in
Germany and Italy. Study Investigator Prof. Giovanni Torsello, MD, of the Department of
Vascular Surgery, St. Franziskus Hospital and University Clinic of
Munster presented the four-year results of the INNOVATION study at
the VEITHsymposium®. The study results showed that after
four years, the INCRAFT® System performed well with
greater than 97 percent freedom from endoleaks and no stent graft
migrations.1
"With the four-year study results demonstrating continued
performance with the INCRAFT® System in Europe, Cordis' device is clinically
established in a class of next-generation AAA devices," said Prof.
Torsello. "In clinical practice, the INCRAFT®
System is easy to use and has one of the lowest profiles of any
endograft on the market. I strongly believe that the
INCRAFT® System will continue to be a valuable option
for physicians who remain eager for new technologies to enhance
their ability to effectively treat patients with AAA."
The INCRAFT® System is intended for the endovascular
treatment of patients with infrarenal AAA and features innovative
technologies designed for durability, conformability, placement
accuracy and sealing without the need for polymers. The
INCRAFT® System is an ultra-low profile EVAR system with
a 14 French (F) outer diameter, including the integrated sheath,
which is equivalent to a 12F catheter sheath introducer profile.*
Most EVAR stent grafts have a system profile ranging from 16F to
22F in size.
"We spent nearly a decade working with a talented team of
interdisciplinary cardiovascular physicians to perfect the design
of the INCRAFT® System and ensure the device would
enable greater access to a life-saving therapy for AAA patients,"
said David Wilson, president, Cordis
Corp., a Cardinal Health company. "Today, the INCRAFT®
System is being used by doctors in regions around the world and the
safety, durability and performance of the device is supported by a
growing body of evidence as seen with the four-year INNOVATION
study data."
The INCRAFT® System is approved for use and available
for sale in Europe, Canada, Mexico, Colombia and Brazil. The
INCRAFT® System is for investigational device use only
in the U.S. and Japan, having been
studied in the INSPIRATION Trial, which completed enrollment in
2013.
About AAA and Endovascular Aortic Repair (EVAR)
An
estimated 24 million people worldwide suffer from AAA, an abnormal
enlargement of the large blood vessel (aorta) that supplies blood
to the abdomen, pelvis and legs. Most patients with AAA do not
experience any noticeable symptoms, which is why AAA is commonly
referred to as the "silent killer." While the cause is not
well-known, an aneurysm may develop in the lower part of the aorta
and cause it to weaken as it enlarges or bulges. As the aorta is
the largest blood vessel in the body and main supplier of blood to
the body, a damaged or ruptured AAA can cause life-threatening
bleeding. EVAR is a minimally invasive alternative to open surgery
for the repair of an AAA. The procedure involves the placement of a
stent graft into the aneurysm through a small incision in the groin
to prevent the aneurysm from rupturing.
About VEITHsymposium®
Now in its fourth decade,
VEITHsymposium® provides vascular surgeons,
interventional radiologists, interventional cardiologists and other
vascular specialists with a unique and exciting format to learn the
most current information about what is new and important in the
treatment of vascular disease. The five-day event features over 900
rapid-fire presentations from world-renowned vascular specialists
with emphasis on the latest advances, changing concepts in
diagnosis and management, pressing controversies and new
techniques. To register to attend the VEITHsymposium®,
please visit www.VEITHpress.org or contact Pauline
T. Mayer at 631.979.3780.
About Cordis Corporation
Cordis Corporation, a
Cardinal Health company, is a worldwide leader in the development
and manufacture of interventional vascular technology. Through the
company's innovation, research and development, Cordis partners
with experts worldwide to treat millions of patients who suffer
from vascular disease. More information about Cordis Corporation
can be found at www.cordis.com.
*16F outer diameter for the 34mm aortic bifurcate
1Cordis data on file
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SOURCE Cardinal Health