New Data Shows Cook Incorporated's Zenith® AAA Endovascular Graft Demonstrates Superior Stability and Effectiveness Over Two Years
June 7, 2004
Bloomington, Ind. – Patients treated for abdominal aortic aneurysms (AAA) with the Zenith® AAA Endovascular Graft achieved a 97.7-percent AAA survival rate, had no aneurysm ruptures occurring in the second year of follow-up, and experienced few complications from the life-saving device after two years, according to the latest data released by Cook Incorporated at the Vascular 2004 Annual Meeting in Anaheim, Calif.
The two-year U.S. findings confirm earlier clinical trial data showing that AAA patients receiving the Zenith AAA endograft achieved remarkable results in the areas of stent migration, endoleaks and aneurysm shrinkage. These three measurements are the most important performance indicators for endovascular grafts. Cook’s remarkably high performance in each area, the company contends, is why the Zenith AAA endograft is the market-leading endovascular graft system outside of the United States and is rapidly gaining domestic marketshare.
Specifically, after the second year of a 15-center, 352-patient clinical trial, data for the Zenith AAA Endovascular Graft show:
- Zero percent stent migration (equal to or greater than 10 mm) in both standard and high-risk patients.
- Endoleaks of any type occurred in only 7.5 percent of all patients, and in only 6.9 percent of standard risk patients, a comparable rate to first-year data.
- The diameter of aneurysms remained unchanged or decreased for 97.4 percent of all patients, and in 100 percent of Zenith patients without endoleaks or systemic infection.
“The two-year results from our Zenith AAA graft system are a strong testament to the product’s technological superiority and proven effectiveness for treating patients with these types of aneurysms,” stated Barry Thomas, global leader of Cook Incorporated’s endovascular therapies division. “These findings, coupled with the long-term experience of physicians in Europe, Australia and other countries, clearly demonstrate Zenith’s constant and stable performance. We expect the long-term rates of endoleaks, migration and aneurysm sac shrinkage to achieve this same level of success well into the future.”
The advanced features of the Zenith AAA system include suprarenal fixation with anchoring barbs and a modular graft design incorporating woven polyester supported by independent, stainless steel Z-stent bodies to provide increased stent/vessel apposition to minimize endoleaks and graft migration. The Zenith endograft’s extended, low iliac graft bifurcation provides columnar strength and simplifies cannulation of the contralateral limb. The Zenith AAA graft system’s modular design offers more than 50,000 possible combinations to treat a wide variety of patient anatomies.
The company introduced its latest-generation endograft design, the advanced Zenith Flex™ AAA Endovascular Graft, at the Vascular 2004 meeting. Cook also is developing a potent portfolio of new aortic endovascular therapies using the Zenith’s patented Z-stent endograft design. Currently, the company is in U.S. clinical trials with the Zenith TX2™ THORACIC TAA Endograft, designed to treat aneurysms in the descending thoracic aorta. Other new devices in development include endografts for use in emergency cases where the aneurysm already has ruptured; and fenestrated and branch vessel versions of Cook’s Zenith device to treat more complex aneurysm cases.
Abdominal aortic aneurysm is a life-threatening condition that occurs when a section of the abdominal aorta, the body’s main circulatory vessel, weakens and bulges outward to form a fragile, balloon-like swelling – an aneurysm. If the aneurysm ruptures, the patient is at high risk for death due to internal bleeding. Traditionally, patients diagnosed with AAA – approximately 200,000 every year in the United States – have had to undergo an open surgical procedure requiring an incision the full length of the patient’s abdomen and exposure of the body’s internal organs to reach the aneurysmal site. A vascular surgeon then must clamp off the aorta to sew a surgical graft in place to prevent the aneurysm from rupturing. Such open surgical procedures carry significant health risks for many older patients, who also may suffer from other medical conditions such as diabetes or hypertension.
With Cook’s Zenith AAA Endovascular Graft, many patients with these types of aneurysms no longer have to undergo open surgery. When treated with the Zenith system, the patient receives two incisions in the groin to allow the insertion of two catheters into the femoral arteries. Once the catheters are guided under x-ray observation into position through the patient's arteries, a fabric-covered, self-expanding metal stent-graft is deployed inside the weakened section of the aorta and the surrounding vessels, helping to relieve pressure on the aneurysm.
“Physicians in the United States and around the world are adopting the Zenith AAA Endovascular Graft enthusiastically for most, if not all, of their endovascular AAA patients due to the device’s ease of use and overall benefits, as well as the level of physician support and training we provide,” explained Thomas.
To date, more than 12,000 Zenith endografts from Cook have been placed in patients worldwide and more than 1,300 U.S. physicians have received clinical instruction in Cook’s industry-unique Zenith physician training program.
For additional patient and physician information on Cook’s Zenith AAA Endovascular Graft, please visit www.zenithstentgraft.com.
With international headquarters in Bloomington, Ind., privately held COOK® (www.cookgroup.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, tissue-engineered medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.
Sign up here to receive e-mail from Cook on clinical updates, new product details and educational opportunities.
Sign Up »