Healthcare Industry News:  Cook 

Devices Interventional FDA

 News Release - January 24, 2008

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.

“This is another major step forward in Cook’s ongoing efforts to make the most sophisticated technology for endovascular aneurysm repair (EVAR) available to patients suffering from aneurysmal disease throughout the aorta,” explained Barry Thomas, vice president of Cook Medical’s aortic intervention business unit. “With the Zenith Branch Endovascular Graft, we can extend the same advanced endograft technology currently available for treating abdominal and thoracic aneurysms to a new class of patient whose aneurysm extends into the iliac arteries.”

“Endovascular repair of all types of aortic aneurysmal disease is growing at a rapid rate due to its minimally invasive nature and positive patient outcomes,” said Dr. Lee. “I am pleased to be leading this important clinical trial, the outcome of which may well add yet another endovascular option for aneurysm patients who otherwise might require a more invasive open surgical procedure or suffer the debilitating consequences of reduced pelvic blood flow secondary to intentional blockage of the internal iliac artery.”

About the Zenith Branch Endovascular Graft

Built on the proven Zenith endograft platform, the Zenith Branch Endovascular Graft expands the endovascular treatment options for aortoiliac or iliac aneurysms. The branch vessel device is intended to preserve` blood flow to the internal iliac, reducing the potential for ischemic sequalae, as well as buttock claudication, colon ischemia, hip claudication, and impotence.

About Cook Medical

Cook Medical was the first company to introduce interventional devices in the United States. Today, the company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes. Cook won the prestigious Medical Device Manufacturer of the Year for 2006 from Medical Device and Diagnostic Industry magazine. For more information, visit www.Cookmedical.com.


Source: Cook Medical

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