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 News Release - January 22, 2008

Cook Medical Begins Patient Enrollment in STABLE Aortic Dissection Trial

Global Clinical Trial to Evaluate the First Device Specifically Designed to Treat Aortic Dissection has Commenced in Melbourne, Australia

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical has begun patient enrollment in the STABLE clinical trial designed to evaluate the Cook Zenith® 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® 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.


Source: Cook Medical

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