Health Canada has approved the Zenith low profile AAA endovascular graft (Zenith AAA LP) from Cook Medical in Canada. This device has a low-profile delivery system diameter of 16 Fr and simplified deployment compared to previous Zenith endograft systems for precise delivery of the graft to the desired position in the patient’s aorta.
Cook will continue offering its existing Zenith Flex AAA endograft system in addition to the new Zenith AAA LP.
“Compared to previous Cook devices, the Zenith LP graft’s low profile system expands the patient population eligible for endovascular aneurysm repair, enabling us to treat patients with small access vessels who might otherwise have to have a conduit procedure for endovascular access. The stent system features barbs, a suprarenal stent, and provides excellent deployment accuracy. Zenith LP’s 16 Fr (18 Fr OD) system gives us more reassurance for doing percutaneous endovascular aneurysm repair as well,” said Cherrie Abraham, vascular and endovascular surgeon, Jewish General Hospital and McGill University, Montreal, Canada.
Cook’s new Zenith AAA LP device has a significantly smaller profile than Cook’s other EVAR delivery systems, which measure 20-24 French. The newly engineered stent-graft is based on the company’s ARC Technology, which combines a series of barbs that engage the aortic wall to provide active fixation, radial force from self-expanding z-stents for stability and optimal graft-to-vessel apposition, and a long main body with columnar strength.
While larger EVAR systems must use a surgical incision to access the femoral artery, in some patients the Zenith AAA LP can be inserted into the femoral artery percutaneously. With this approach, both the wire guide and delivery sheath are introduced by a needle inserted into the blood vessel through the skin. This procedure allows aortic access without the need for a surgical cut-down of the artery.
The Zenith AAA low profile graft is an investigational device not approved for sale in the United States.
