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UK AAA Endograft trial results look positive

Cook : 14 June, 2007  (New Product)
Cook Aortic Intervention has announced positive findings from the UK elective endovascular aneurysm repair (EVAR) trial.
The trial was led by Professor RM Greenhalgh, head of the Vascular Surgery Research Group at Imperial College, London.

About 15,000 UK residents die each year from AAAs, with the condition being most common in men above the age of 60, and with an increased risk for those with hypertension or peripheral vascular disease.

The EVAR trial generated clinical data used to analyse the secondary intervention rate, aneurysm-related mortality and all-cause mortality for patients receiving EVAR for large abdominal aortic aneurysms using different commercially available endografts.

In the EVAR 1 and 2 multi-centre trials, the principal endografts used were Zenith from Cook and Talent from Medtronic. These are compared in 505 patients from EVAR 1 and 143 patients from EVAR 2 followed up for an average of 3.8 years until 31 December 2005.

Outcomes were analysed by Cox proportional hazards regression, with adjustments for potential confounding risk factors and centre.

Some Gore/Excluder Graft outcomes were also reported, although the device was used in only seven percent of patients.

Across the two trials the secondary intervention rates were 7.0 and 9.4 per 100 patient years for Zenith and Talent grafts respectively, adjusted hazard ratio 0.77 [95 percent CI 0.52-1.12].

Aneurysm-related mortality was 1.2 and 1.4 per 100 patient years for Zenith and Talent grafts respectively, adjusted hazard ratio 0.90 [95 percent CI 0.37-2.19].

All-cause mortality was 8.5 and 10.3 per 100 patient years for Zenith and Talent grafts respectively, adjusted hazard ratio 0.81 [95 percent CI 0.58-1.14].

'The direction of results favours Zenith patients across the reported criteria', comments Barry Thomas, global leader of Cook's Aortic Intervention business division. 'At Cook, we approach medical device creation with the patient in mind'.

'As a result, the Zenith device has become the most-used AAA endograft in the world, a choice these results confirm as being in the best interests of the patient'.

Cook's Zenith AAA Endovascular Graft has regulatory approval for sale in the UK, Canada, Europe, Australia and New Zealand, Japan, Taiwan, and other major markets.
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