"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 US," said Barry Thomas, global leader of Cook'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 US market shortly."
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%, 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 said.
Cook is also 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 US 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 US physicians have received clinical instruction in Cook's industry-unique Zenith physician training program.
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