Cook Incorporated Files IDE Application for Zenith Branch Vessel Graft with U.S. FDA

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Incorporated, the world leader in endovascular repair of aortic disease, has filed an Investigational Device Exemption (IDE) for a new type of endograft designed to treat patients with aortoiliac or iliac aneurysms that have been difficult to treat endovascularly with currently available designs.
The company has asked the U.S. Food and Drug Administration (FDA) for permission to initiate a clinical trial of the Zenith Branch Endovascular Graft-Iliac Bifurcation with the H&L-B One Shot Introduction System at 10 sites. Once the application has been reviewed and approved, National Principal investigator W. Anthony Lee, M.D., associate professor of surgery at the University of Florida in Gainesville, Florida, will lead the trial along with a select group of U.S. vascular surgeons at leading healthcare institutions around the country. The trial is expected to take about one year to enroll.

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