Cook Medical Announces First Enrolment In European Arm Of Global Trial Of Unique Device To Treat Aortic Dissection

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Medical Devices
Article Date: 22 Mar 2008 - 1:00 PDT

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German patient is first in Europe to receive the first-of-its-kind Zenith Dissection Endovascular System in the STABLE trial.

Christoph A. Nienaber M.D., Ph.D., site investigator at the University of Rostock in Germany, has just completed the first European case in a global clinical trial designed to evaluate the Cook Zenith® Dissection Endovascular System for the treatment of Type B thoracic aortic dissections. This is the first device designed specifically to treat aortic dissections, the aortic tearing condition that took the life of American actor John Ritter. The technologically advanced device is the first of its kind worldwide and was designed to treat the unique morphology of this under-diagnosed disease, a major cause of mortality worldwide that often can be misdiagnosed as a heart attack based on its symptoms.

Dr. Nienaber, who serves as head of cardiology at the University of Rostock, Rostock, Germany, was assisted during the procedure by colleagues Huseyin Ince, M.D., Ph.D.; Thomas Korber, M.D.; and Stephan Kische, M.D. The global principal investigator for the trial is Joseph Lombardi, M.D., assistant professor at Thomas Jefferson University Hospital in Philadelphia, Penn., USA.

"This is the first real dissection-specific endovascular approach to this condition," Dr. Nienaber said of his experience with the Cook Zenith Dissection Endovascular System. "It stabilises the entire dissection with a 'petticoat' (stent graft and bare stent) without compromising important abdominal side branches."

The first European patient found suitable for inclusion in the STABLE dissection clinical trial was a 71-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. A Zenith TX2 Proximal Tapered Component stent graft sealed the entry tear in the thoracic aortic arch, and a bare Zenith Dissection Endovascular Stent was placed in the region where the aorta's true lumen had collapsed.

"We are proud to announce the enrolment of the fist European patient in the STABLE trial as it marks our continued effort to treat thoracic aortic dissections worldwide," said Phil Nowell, global director of Cook's Aortic Intervention strategic business unit. "We anticipate that the STABLE trial will confirm the success of the Cook Zenith Dissection Endovascular System and highlight the positive outcomes for our patients. We are delighted to have Dr. Nienaber as an investigator in the study as he plays an integral role in Cook's mission to offer patients the least invasive treatment options, ultimately leading to a successful and speedy recovery."

The Cook Zenith Dissection Endovascular System is used in the endovascular treatment of descending thoracic aortic dissection in patients with anatomies appropriate for endovascular repair. The device has unique Z-stents that exert pressure allowing gradual apposition of the dissection septum and re-expansion of the true lumen, while keeping important arteries exposed that supply the spinal cord with blood.

Endovascular aortic repair (EVAR) may potentially offer a solution that will eliminate 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 then 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 European Union or 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 one of the first companies 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 from Medical Device and Diagnostic Industry magazine. For more information, visit http://www.cookmedical.com.