Healthcare Industry News:  abdominal aortic aneurysm 

Devices Interventional FDA

 News Release - October 31, 2006

Cook Incorporated Receives FDA Approval for Breakthrough Endovascular Graft

Company's 36mm Zenith(R) FLEX(TM) AAA Endovascular Graft and Delivery System Provides A Minimally Invasive Treatment for Cases of abdominal aortic aneurysms

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Incorporated has received approval from the U.S. Food and Drug Administration (FDA) for its new 36mm Zenith FLEX AAA Endovascular Graft for the treatment of abdominal aortic aneurysms (AAA), company officials report. The state-of-the-art aortic endograft is designed to provide an effective, minimally invasive treatment option for patients with large abdominal aortic neck diameters who previously may not have been candidates for endovascular aortic repair (EVAR).

AAA, a life-threatening disease 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 called an aneurysm. If the aneurysm ruptures, the patient is at high risk of death as a result of internal bleeding.

With FDA clearance of Cook's 36mm Zenith FLEX AAA Endovascular Graft and 22 French H&L-B One-Shot Introduction System with Flexor Sheath and Captor Hemostatic Valve, physicians can offer an endovascular solution for the interventional treatment of AAA in large aortic necks ranging from 29mm to 32mm in diameter. Cook's Zenith AAA endograft is the world's largest-selling device of its kind and currently is in use in the U.S., Canada, Japan, the European Union, Australia, Latin America and other major markets.

"We are pleased that the FDA has approved our 36mm Zenith Endovascular Graft, a unique device that will help a much broader range of patients with AAAs," said Barry Thomas, global leader of Cook Incorporated's Endovascular Therapies group. "The 36mm Zenith endograft's enhanced design offers physicians an unparalleled treatment option for those patients who may have otherwise been untreatable. The release of the 36mm Zenith FLEX and accompanying 22 French introduction system demonstrates Cook's dedication to addressing the unique and individual needs of each and every patient."

Cook continues to experience tremendous growth and demand for its Zenith product family. The company has seen its market share increase in the rapidly growing market for AAA endografts. In 2006, more than 19,000 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.

Availability

The 36mm Zenith FLEX Endovascular Graft with 22 French H&L-B One-Shot Introduction System is available immediately.

About Cook Incorporated

The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOKŪ (www.cookmedical.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 drug-eluting stents and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and women's health, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.


Source: Cook Inc

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