Cook's 36mm Zenith Flex AAA endovascular graft and delivery system offers minimally invasive treatment for previously untreatable cases of abdominal aortic aneurysms
Cook has received CE approval for its new 36mm Zenith Flex AAA Endovascular Graft for the treatment of abdominal aortic aneurysms (AAA).
This 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 diagnosed in tens of thousands of cases annually in Europe and the UK, 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 CE approval for Cook's 36mm Zenith Flex AAA Endovascular Graft preloaded onto the 22 French HandL-B One-shot introduction system with flexor sheath and captor hemostatic valve.
Physicians in the UK and the European Union now can offer an endovascular solution for the interventional treatment of AAA in large aortic necks ranging from 29mm to 32mm in diameter.
Rod Chalmers, consultant vascular surgeon, Royal Infirmary of Edinburgh comments: "This exciting development will allow us to treat patients with infra-renal aneurysms by endovascular means who would previously not have been suitable".
Cook already is the market leader in the UK for this innovative technology, with a 41 per cent market share in the UK for AAA stent grafts and ancillary products.
In the European Union, Zenith also holds the top position in sales and market share with a 38 per cent market share.
Worldwide, Cook's Zenith AAA endograft is the largest-selling device of its kind and currently is in clinical use in the USA, Canada, Japan, the European Union, Australia, Latin America and other major markets.
"We are pleased that we now have CE approval for our 36mm Zenith Endovascular Flex 36mm Graft, a unique device that will help a much broader range of patients with AAAs enjoy the clinical benefits of minimally invasive treatment," said Barry Thomas, global leader of Cook Medical's aortic intervention global business unit.
"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.
More than 1000 UK and EU physicians have received clinical instruction in Cook's industry-unique Zenith physician training programme.
Availability: the 36mm Zenith Flex AAA Endovascular Graft with 22 French HandL-B One-Shot Introduction System will be available to physicians in March 2007.
