Cook applauds new Dutch study supporting endovascular repair as effective long-term option for aneurysm patients

Bloomington, Ind. – A new Dutch medical study comparing two-year survival data for abdominal aortic aneurysm (AAA) patients supports endovascular repair as having a lower aneurysm-related death rate than traditional surgical treatment, officials at Cook Incorporated said.

The randomized study of 351 AAA patients, which examined two-year survival rates between patients undergoing open surgical treatment compared to patients receiving endovascular repair, showed cumulative survival rates of 89.7 percent for endovascular treatment and 89.6 percent for surgical treatment. Aneurysm-related mortality was lower for endovascular repair than open surgical repair (5.7 percent for open vs. 2.1 percent for endovascular, p = 0.05). The report appeared in yesterday’s New England Journal of Medicine.

Given that the purpose of an endograft is to avoid aneurysm-related death, this study is good news for endovascular treatment, Cook officials stressed. The study results confirm two-year results from Cook’s multicenter U.S. pivotal trial of its market-leading Zenith endograft that showed AAA survival rates at 98.9 percent (1.1 percent mortality) for standard risk aneurysm patients treated with the Zenith endograft.

“Endovascular repair of aortic aneurysms was developed originally to provide a treatment option for aneurysm patients unable to undergo the highly invasive open surgical procedure, which can pose a significant risk of severe complications in the sickest patients,” said Kem Hawkins, president of Cook Incorporated. “Data being reported now confirm that not only does endovascular treatment offer significant clinical advantages such as shorter recovery times and lower rates of in-hospital complications during the first 30 days after the procedure, longer-term survival rates and other key indicators of favorable clinical outcomes are comparable between surgical and endovascular treatment, which was our initial goal for this emerging technology.”

Abdominal aortic aneurysm is a life-threatening condition that occurs when a section of the 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 heart disease, 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 aneurysm patient receives two surgical 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.

To date, more than 20,000 Zenith endografts from Cook have been placed in patients worldwide, and more Zenith endografts have been sold in 2005 than any other device for endovascular treatment of AAA. More than 1,500 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.

The world’s largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK® (www.cookmedical.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 drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and Ob/Gyn, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.

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