Bloomington, Ind. – The Zenith® AAA Endovascular Graft from Cook Incorporated, the leading selling endovascular graft system outside the United States for treating abdominal aortic aneurysms (AAA), has received premarket approval (PMA) clearance from the U.S. Food and Drug Administration for domestic distribution. The device is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.

Clearance was based on a 15-center, 352-patient clinical trial conducted between January 2000 and July 2001 with 1-, 6- and 12-month patient follow-up. The study met all clinical endpoints, in addition to achieving 0 percent stent migration equal to or greater than 10 mm, a 99.7 percent device deployment success rate, a 98.7 percent rate of aneurysm diameter decreasing or remaining unchanged, and a 7.4 percent rate for all types of endoleaks.

The Zenith AAA graft system, a third-generation stent-graft system for the endovascular treatment of AAA, features a modular design with more than 50,000 possible combinations to treat a wide variety of patient anatomies, explained David Biggs, director, advanced technology management, Cook Incorporated.

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 graft’s extended, low iliac graft bifurcation provides columnar strength and simplifies cannulation of the contralateral limb.

The proprietary Zenith H&L-B One-Shot™ Introducer System uses a sequential deployment method providing continuous control of the entire graft system throughout the procedure. This system enables precise placement with the ability to readjust the graft before fully deploying the anchoring barbs.

“We expect a similar adoption curve in the U.S. to what we’ve experienced overseas,” Biggs explained. “Once physicians become aware of the potential benefits inherent in the Zenith design, a very large number of them decide to adopt this technology for most, if not all, of their AAA patients.”

Cook also is developing new AAA graft therapies using the Zenith design that flex to fit a broader range of patient anatomy. Future uses of Cook’s Zenith technology also may include grafts designed to treat aneurysms in the thoracic aorta and for use in emergency cases where the aneurysm has already ruptured. To date, more than 10,000 Zenith grafts have been placed in patients and more than 1,000 U.S. physicians have signed up for clinical training in the Zenith deployment procedure.

For additional information on the Zenith AAA Graft System, 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, medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.