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Cook Offers First Fenestrated Endograft With CE Mark Approval For Complex Aortic Aneurysms

Bloomington, Indiana, Oct. 25, 2005 -- The Zenith® Fenestrated AAA Endovascular Graft has received CE Mark certification, making it the first endograft commercially available in the European Union to treat complex abdominal aortic aneurysms where access to an adjoining blood vessel must be maintained by the graft to perfuse vital organs, Cook Incorporated announced today.

Cook's new device is the first in the world to incorporate tailored openings or scallops called fenestrations in the top section of the endograft. This design breakthrough allows the self-expanding stent-graft to treat aortic and aortoiliac aneurysms extending close to the renal and superior mesenteric arteries, which are then stented to reduce the risk of restricting or blocking critical blood flow to the kidneys and bowel. Each fenestrated device is custom-made to suit individual patients' anatomy by Cook's endograft manufacturing division in Australia.

"The Zenith Fenestrated AAA Endovascular Graft brings the clinical advantages of endovascular treatment to a new subset of patients with highly demanding aneurysms who previously may not have been candidates for endovascular repair. With this milestone, Cook has taken a major step toward its goal of providing physicians with the industry's only comprehensive set of endografts and accessories for treating aneurysms and other morbidities along the entire length of the aorta," said Barry Thomas, global leader of Cook's endovascular therapy products division. "We expect the Zenith Fenestrated Endograft to provide a new option to European physicians treating AAA patients who cannot be treated using standard, off-the-shelf endograft components. We hope to make this exciting technology available in the U.S. in the very near future."

Cook already has enrolled the first 18 patients in its U.S. pilot study of the Zenith fenestrated endograft. The trial will enroll 30 patients at six U.S. institutions for the treatment of abdominal aortic or aortoiliac aneurysms. The U.S. study's national principal investigator is Roy Greenberg, M.D., director of endovascular therapies at the Cleveland Clinic.

"Fenestrated endografts for complex aortic aneurysms represent a significant step in the evolution of endovascular repair," said Dr. Greenberg. "For the first time, we're seeing the possibility of offering safe, effective endovascular treatment for diseases affecting the more proximal aorta. As branch technology joins the fenestrated family, the entire aorta falls within the domain of aortic interventionalists. This is extremely exciting for those of us involved in management of these complex patients."

This new fenestrated device retains the fundamental design elements that have made the Zenith endograft the world's most widely used endovascular device for treating aortic aneurysms. The major benefits of the Zenith design include suprarenal fixation with anchoring barbs to ensure maximal stability and graft-to-vessel sealing, woven polyester graft material that is lightweight, strong and shrink-resistant, and the H&L-B One-Shot™ Introducer System that allows simple, accurate deployment and positioning of the graft.

The Zenith Fenestrated AAA Endovascular Graft from Cook Incorporated is an investigational device not approved for sale in the U.S. It is available for sale in the European Union, Australia and New Zealand.

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.

About Cook Incorporated
With international headquarters in Bloomington, Ind., COOK® (www.cookgroup.com), the world's largest privately held medical device manufacturer, 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, medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.

Cook Incorporated

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