First Fenestrated Endograft in Cook Inc.'s Study of Advanced Treatment for Aortic Aneurysms Is Implanted In U.S.
January 7, 2005
Bloomington, Ind. – The first fenestrated endograft for the treatment of abdominal aortic aneurysm (AAA) in Cook Inc.’s pilot study of advanced endovascular treatments for this life-threatening condition has been implanted. The procedure was performed at the University of California San Francisco Medical Center by Department of Surgery faculty Darren Schneider, M.D., assistant professor in residence and Timothy Chuter, M.D., associate professor in residence, company officials announced.
Cook’s new device is the first in the world to incorporate custom-tailored openings, called fenestrations, at the top of the endograft. This design breakthrough allows the self-expanding tubelike device to treat that aortic aneurysms extend close to the renal arteries, which are then stented to eliminate the chance of reducing or blocking critical blood flow to the kidneys.
“The initiation of the U.S. clinical trial of our fenestrated endograft for aortic and aortoiliac aneurysms further demonstrates how far Cook has advanced this technology,” explained Barry Thomas, global leader of Cook’s endovascular therapies division. “The Zenith Fenestrated AAA Endovascular Graft brings the clinical advantages of endovascular treatment to a new subset of patients with highly demanding aneurysms who previously may not have been candidates for this procedure.”
Dr. Schneider is principal investigator at UCSF Medical Center for the Zenith Fenestrated AAA Endovascular Graft. The U.S. Food and Drug administration has granted Cook permission to enroll 30 patients at six U.S. institutions for the treatment of abdominal aortic or aortoiliac aneurysms. The study’s national principal investigator is Roy Greenberg, M.D., director of endovascular therapies at the Cleveland Clinic.
AAA is a life-threatening condition affecting more than four million people that occurs when a section of the abdominal aorta, the body’s main circulatory vessel, weakens and bulges outward to form a fragile, balloon-like swelling – an aneurysm. If the aneurysm ruptures, the patient is at high risk of death due to internal bleeding.
Cook continues to see tremendous growth and demand for its Zenith product family. The company has seen its market share increase in the rapidly growing $280 million market for AAA endografts. To date, more than 20,000 Zenith endografts from Cook have been placed in patients worldwide and more than 1,500 U.S. physicians have received clinical instruction in Cook’s industry-unique Zenith physician training program.
With international headquarters in Bloomington, Ind., COOK® (www.cookmedical.com), the world’s largest privately held medical device manufacturer, 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 and other minimally invasive medical devices for radiology, cardiology, urology and OBN/GYN, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.