Global Clinical Trial to Evaluate the First Device Specifically
Designed to Treat Aortic Dissection has Commenced in Melbourne,
Australia
BLOOMINGTON, Ind.--(Business Wire)--Cook Medical has begun patient enrollment in the STABLE clinical
trial designed to evaluate the Cook Zenith(R) Dissection Endovascular
System for the treatment of Type B thoracic aortic dissections. The
technologically advanced device is the first of its kind and was
designed specifically to treat aortic dissection, a major cause of
mortality worldwide. The first STABLE trial patient was treated by
interventional radiologist Peter Mossop, M.D. and cardiac surgeon Ian
Nixon, M.D. at St. Vincent's Public Hospital in Melbourne, Australia.
The first patient found suitable for inclusion in the STABLE
dissection clinical trial was a 60-year-old male diagnosed with a Type
B dissection of his thoracic aorta. The patient was treated with the
Cook Zenith Dissection Endovascular System, which is comprised of the
new Cook Zenith Dissection Stent, used in conjunction with the Cook
Zenith TX2(R) Endovascular Graft. The TX2 Stent Graft repaired the
primary entry tear while the bare metal dissection stents were placed
to expand and support the remainder of the dissected aorta for the
length of the dissection (in this case to the level of the aortic
bifurcation.) The aortic repair was successful, and the patient was
discharged and sent home to spend the holidays with family.
"We are very proud to announce the first of what we anticipate
will be many successful treatments for thoracic aortic dissections
using Cook Medical's Zenith System," said Barry Thomas, vice president
of Cook's Aortic Intervention strategic business unit. "With the
highly skilled support of Dr. Mossop and Dr. Nixon, we are continuing
our efforts to better serve patients affected by thoracic aortic
dissections across the world with the most minimally invasive
treatment available. As this condition affects tens of thousands of
lives annually, we look forward to helping more patients avoid the
trauma of open surgical repair and go on to live healthy lives."
The Cook Zenith Dissection Endovascular System is intended for use
in the endovascular treatment of descending thoracic aortic dissection
in patients with anatomies appropriate for endovascular repair. The
device's unique Z-stent exerts pressure that allows gradual apposition
of the dissection septum and re-expansion of the true lumen, while not
covering over important arteries supplying the spinal cord with blood.
Endovascular aortic repair (EVAR) eliminates the need for highly
invasive, traumatic open surgery for thoracic aneurysms and
dissections. Rather than opening the chest cavity and clamping off the
aorta to surgically implant a graft to treat the damaged section of
the thoracic aorta, physicians insert a catheter loaded with a
self-expanding, fabric covered stent-graft through a surgical opening
in the femoral artery. The catheter is guided through the patient's
blood vessels under fluoroscopy until the device is positioned across
the dissected section of the aorta. The stent-graft expands upon
deployment from the catheter to reopen the original path through the
aorta and reduces blood flow into the false pathway in the damaged
vessel wall, thereby restoring normal aortic blood flow. The uncovered
Zenith Dissection Stent is used to expand the true lumen in the distal
thoracic aorta where preservation of the side branch artery blood flow
is critical.
The Cook Zenith Dissection Endovascular System is an
investigational device not available in the United States. The Cook
Zenith TX2 Endovascular Graft is approved in Europe, Australia and New
Zealand for the treatment of thoracic aortic aneurysms and
dissections.
About Cook Medical
Cook Medical was the first company to introduce interventional
devices in the United States. Today, the company participates in all
global markets, integrating device design, biopharma, gene and cell
therapy and biotech to enhance patient safety and improve clinical
outcomes. Cook won the prestigious Medical Device Manufacturer of the
Year for 2006 from Medical Device and Diagnostic Industry magazine.
For more information, visit www.cookmedical.com.
Cook Medical
David McCarty, 812-339-2235, ext. 2387
Global Public Relations Director
812-322-1805 (mobile)
dave.mccarty@cookmedical.com
or
Racepoint Group
Jackie Hanley, 781-487-4625
jhanley@racepointgroup.com
Copyright Business Wire 2008
