April 25, 2012—Earlier this month, the US Food and Drug Administration (FDA)'s Center for Devices and Radiological Health (CDRH) informed Cook Medical (Bloomington, IN) that the agency had reviewed and approved the company’s premarket approval application supplement for the Zenith fenestrated AAA endovascular graft and the adjunctive Zenith alignment stent. The platform is now indicated for use in the endovascular treatment of patients with abdominal aortic aneurysms (AAAs) or aortoiliac aneurysms having morphology suitable for endovascular repair. A copy of the approval letter can be viewed on the FDA website.
The Zenith fenestrated AAA endovascular graft differs from the standard Zenith AAA device in that it has fenestrations or scallops in the graft material. These allow the proximal edge of the material to be placed above the renal arteries while still permitting blood flow to vessels accommodated by the fenestrations or scallops. In order to account for anatomical variation, each proximal body graft is made to order for a specific patient.
The modular system consists of three components: a proximal body graft, a distal bifurcated body graft, and one iliac leg. The graft modules are constructed of full-thickness woven polyester fabric sewn to self-expanding stainless steel Cook Z stents with braided polyester and monofilament polypropylene suture. These materials are identical to the materials used to construct the standard Zenith AAA endovascular graft, with the new Zenith fenestrated device having a nitinol wire ring around the graft fenestrations.
Ancillary devices that are currently available for the standard Zenith device, such as main body extensions, iliac leg extensions, converters, and iliac plugs, may also be required.
The FDA notification describes AAA/aortoiliac aneurysm morphology that is suitable for treatment using this device as follows:
•Adequate iliac/femoral access compatible with required introduction systems
•Nonaneurysmal infrarenal aortic segment (neck) proximal to the aneurysms with length ≥ 4 mm and unsuitable for a nonfenestrated graft; diameter ≤ 31 mm and ≥ 19 mm; angle < 45º relative to the long axis of the aneurysm; and, angle < 45º relative to the axis of the suprarenal aorta
•Ipsilateral iliac artery fixation site > 30 mm in length and between 9 and 21 mm in diameter
•Contralateral iliac artery distal fixation site > 30 mm in length and between 7 and 21 mm in diameter.
The Zenith alignment stent is indicated for use as an adjunct to the Zenith fenestrated AAA endovascular graft to secure positive alignment of fenestrations or scallops with the orifice of aortic branch vessels having diameters ranging from 3 to 8 mm.
The FDA’s complete summary of the device’s safety and effectiveness data, indications for use, product specifications with illustrations, and product labeling information are available on the FDA website.
Commercial US launch of the Zenith fenestrated AAA endovascular graft is anticipated in summer 2012.
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