FDA Approves Next-Generation Zenith FLEX™ Advanced AAA Endograft From Cook Incorporated
June 3, 2004
Bloomington, Ind. – In a regulatory move that further solidifies Cook Incorporated’s technological leadership in designing highly advanced endografts for treating aortic aneurysms, the Food and Drug Administration has approved Cook’s next-generation Zenith® FLEX™ AAA Endovascular Graft for U.S. distribution, company officials reported today.
“The Zenith FLEX design represents what we believe is the most technologically advanced endograft for abdominal aortic aneurysms (AAA) approved for commercial distribution in the U.S.,” said Barry Thomas, global leader of Cook Incorporated’s endovascular therapies division. “We’re thrilled to have FDA approval for our next-generation Zenith FLEX AAA endograft, and look forward to introducing it to the U.S. market shortly.”
Cook will unveil the new device at the Endovascular 2004 meeting of the Society for Vascular Surgery in Anaheim, CA on June 3-6.
The Zenith FLEX AAA graft system features several significant innovations, Thomas explained. These advanced features include more widely spaced stent bodies to allow the device to conform to tortuous anatomy. The new design also decreases the Zenith FLEX stent-graft’s kink radius by 40-68 percent, allowing the device to bend around tighter turns in the aorta with less chance of kinking, the company reports.
Before launching the new Zenith FLEX endograft, Cook officials said they are waiting to receive FDA clearance on a new, more advanced delivery system that takes full advantage of the new endograft’s advanced features. The next-generation H&L-B One Shot™; delivery system features Cook’s new Captor™ Hemostatic Valve to inhibit blood reflux and air aspiration. It also features a Flexor® introducer that uses a unique sheath construction to combine optimal flexibility with maximum resistance to sheath kinking or compression. FDA clearance is expected soon, Thomas added.
Cook also is developing a potent portfolio of new aortic endovascular therapies using the Zenith’s patented Z-stent endograft design, Thomas added. Already, the company is in U.S. clinical trials with the Zenith TX2 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 has already ruptured; and fenestrated and branch vessel versions of Cook’s Zenith device to treat more complicated aneurysm cases. 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.
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.