Promising results for redeployable graft

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The latest European experience with the Anaconda stent graft (Vascutek) – the first device for treating abdominal aortic aneurysm that can be fully repositioned – was presented at the CX Symposium on Sunday 5 April 2009.

Donald Reid of the Wishaw Hospital, Scotland, related the story of the first graft in the UK. Reid’s own father travelled from Glasgow to London to ask a tailor to cut the hem off a shirt, which was then used as a graft.

“Times have moved on, though. In Scotland we now make our own endoluminal devices. And I’d like to share our experience with the Anaconda device.”

Anaconda – manufactured by Vascutek in Renfrewshire, Scotland – is a modular endograft made of ultra-thin woven polyester, with new features that make it easy to insert and position accurately.

“It has two significant advantages. It is redeployable in the aortic neck. This means that it can be adjusted in its position for more accurate placement. It also has a clever magnet system in order to gain contralateral access more easily,” said Reid.

A unique control system enables the device to be orientated and positioned to accommodate tortuous anatomy. The Anaconda features an intrinsic magnet wire that, together with a separate magnetic guidewire, facilitates rapid contralateral access.

The dual proximal ring stents feature multiple turns of nitinol wire that, together with four pairs of double hooks, provide a clinically-proven sealing function with positive fixation and security against stent graft migration.

“I must say that, when I first saw this, I thought it was a bit of a gadget. But in practice it’s been absolutely fabulous.”

Reid presented data from a European multicentre trial that was used to gain CE approval and reviewed clinical publications on the system. At two-year follow-up, this study of 61 patients reported no perioperative death, no type I, III, or IV endoleaks, five type II endoleaks and one limb occlusion.

Reid also presented data from studies from Italy and Greece.

The Italian study included 49 patients (Eur J Endovasc Surg 2007;34(6):693-8) and reported one perioperative death, no type I, III, or IV endoleaks and 12 of type II, two limb occlusions, and no instances of migration.

The Greek study (J Endovasc Ther 2008;15:33-41) of 51 patients reported no perioperative death, one type I endoleaks and four type II, one limb occlusion, and no migration.

He also discussed early results from his own ongoing study of 100 patients in Scotland, which showed similarly positive results.

Anaconda has completed a phase I safety study, and will begin a phase II trial in May, in pursuit of approval to market the graft in the USA.

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