Trial Shows Positive Results Using Cook Medical's Zenith Abdominal Aortic Aneurysm Endovascular Stent Versus Open Surgical Repair

Main Category: Vascular
Also Included In: Medical Devices / Diagnostics
Article Date: 26 Jun 2008 - 1:00 PDT

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A non-randomised, controlled study, led by Roy K. Greenberg, M.D., generated positive results on the Cook Zenith Abdominal Aortic Aneurysm (AAA) Endovascular Graft for endovascular aortic repair (EVAR), Cook Medical reported today. The trial results indicated that the EVAR procedure, using the Cook Zenith, is a safe and effective alternative to open surgical repair for the treatment of AAAs. The results were presented June 6 at the 62nd annual meeting of the Society for Vascular Surgery in San Diego, California and will be published in the July issue of the Journal of Vascular Surgery.

Dr. Greenberg, along with trial investigators Timothy A. Chuter, M.D., Richard P. Cambria, M.D. and W. Charles Sternbergh, III, M.D., presented five-year data on 739 patients in the multicenter trial. The study compared the minimally invasive EVAR procedure using the Cook Zenith device to a control group that underwent open surgical repair to treat abdominal aortic aneurysms.

The middle- and long-term data evaluating the Cook Zenith AAA Endovascular Graft found long-term durability, a significantly low risk of aneurysm-related death or rupture, and infrequent complications of migration, limb occlusion and device integrity issues. Specifically, the study demonstrated that for Zenith patients at standard and high medical risk, aneurysm-related death was two percent and four percent; and freedom from rupture was 100 percent and 99.6 percent, respectively. Overall, the cumulative risk of conversion, limb occlusion, migration > 10 mm, or component system was less than or equal to three percent at five years.

"Based on the clinical data obtained during this extensive trial, the Zenith AAA Endograft System should be considered a benchmark against which other AAA endografts should be compared," Greenberg said during his presentation.

AAA occurs when a section of the aortic wall, the body's main blood vessel, weakens and creates a dangerous bulge that could rupture, an often-fatal occurrence.

Endovascular aneurysm repair was first introduced to the United States in 1999. A less-invasive alternative to open surgery, EVAR is performed by making two small incisions in the groin and threading two catheters through the patient's arteries. Once in place in the weakened section of the aorta, the catheters release a tubular device comprised of large z-shaped metal stents sewn to surgical graft material that expands to channel blood through the aorta and reduce the pressure on the aneurysmal sac, lessening the risk of rupture. The recovery time for EVAR is considerably shorter than that of open surgery, decreasing hospital stays down to two to three days. EVAR patients normally return to normal activities within weeks, compared to months with open surgery.

"EVAR has undeniably revolutionised the way life-threatening AAAs are treated in thousands of patients worldwide," said Phil Nowell, global leader of Cook Medical's Aortic Intervention strategic business unit. "This positive, five-year clinical data serves as yet another proof point that our advanced Zenith design, coupled with the minimally-invasive EVAR procedure, provides patients with the best combination of medical technology to treat abdominal aortic aneurysms."

Today, Cook Medical stands as the global sales leader in the endovascular aortic aneurysm repair market. Cook's Zenith AAA Endovascular Graft is approved for sale in Europe, Australia, New Zealand, Japan, Taiwan, Canada, the United States, South America and other markets. The "Cook Zenith® AAA Endovascular Graft Five-Year User Report" is available for download at http://www.cookmedical.com/ai

About Cook Medical

Cook Medical was one of the first companies to help popularise interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine.

Cook Medical

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