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Cook Medical Zenith Spiral Leg Graft wins FDA PMA

Cook Medical has received the premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Zenith Spiral-Z abdominal aortic aneurysms (AAA) Iliac Leg Graft used to treat patients that require graft support in the iliac artery.

Cook Medical said the graft features flexibility and kink resistance due to a continuous nitinol spiral stent.

The graft also offers radial force at the proximal sealing site with company’s technology in sealing stent design.

The Zenith device’s Z-Trak Introduction System features a PTFE-coated lumen to reduce surface friction and facilitate device delivery.